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Varibar Nectar

These highlights do not include all the information needed to use VARIBAR NECTAR safely and effectively. See full prescribing information for VARIBAR NECTAR.

Approved
Approval ID

5e7045f7-b771-d8af-ce30-be95b2597c10

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 9, 2020

Manufacturers
FDA

E-Z-EM Canada Inc

DUNS: 204211163

Products 2

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 Code32909-116
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2020
FDA Product Classification

INGREDIENTS (16)

waterInactive
Code: 059QF0KO0R
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
dimethicone 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311
Classification: IACT
Barium SulfateActive
Quantity: 400 mg in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
dimethicone 1000Inactive
Code: MCU2324216
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
maltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
xylitolInactive
Code: VCQ006KQ1E
Classification: IACT

barium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code32909-115
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2020
FDA Product Classification

INGREDIENTS (16)

maltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311
Classification: IACT
dimethicone 1000Inactive
Code: MCU2324216
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
Barium SulfateActive
Quantity: 400 mg in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
dimethicone 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
potassium sorbateInactive
Code: 1VPU26JZZ4
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
xylitolInactive
Code: VCQ006KQ1E
Classification: IACT

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Varibar Nectar - FDA Drug Approval Details