Readi-Cat 2

These highlights do not include all the information needed to use READI-CAT 2 and READI-CAT 2 SMOOTHIE products safely and effectively. See full prescribing information forREADI-CAT 2 (barium sulfate) oral suspensionREADI-CAT 2 SMOOTHIE (barium sulfate) oral suspensionInitial U.S. Approval: 2016

Approved

Approval ID

d2d293d5-dcc9-0d3f-58ed-686ef0132d7c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2020

Manufacturers

FDA

E-Z-EM Canada Inc

DUNS: 204211163

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-777

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-756

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-742

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-746

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-747

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-711

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-722

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-744

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (11)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-724

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (11)

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

waterInactive

Code: 059QF0KO0R

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

Barium Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code32909-741

Application NumberNDA208143

Product Classification

Marketing Category

C73594

Generic Name

Barium Sulfate

Product Specifications

Route of AdministrationORAL

Effective DateOctober 12, 2020

FDA Product Classification

INGREDIENTS (13)

Barium SulfateActive

Quantity: 20 mg in 1 mL

Code: 25BB7EKE2E

Classification: ACTIB

anhydrous citric acidInactive

Code: XF417D3PSL

Classification: IACT

dimethicone 1000Inactive

Code: MCU2324216

Classification: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLU

Classification: IACT

sodium benzoateInactive

Code: OJ245FE5EU

Classification: IACT

benzoic acidInactive

Code: 8SKN0B0MIM

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4

Classification: IACT

sorbitolInactive

Code: 506T60A25R

Classification: IACT

trisodium citrate dihydrateInactive

Code: B22547B95K

Classification: IACT

xanthan gumInactive

Code: TTV12P4NEE

Classification: IACT

saccharin sodiumInactive

Code: SB8ZUX40TY

Classification: IACT

waterInactive

Code: 059QF0KO0R

Classification: IACT

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Readi-Cat 2

Products 10

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

Barium Sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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