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Penicillin V Potassium

PENICILLIN V POTASSIUM TABLETS, USP / PENICILLIN V POTASSIUM FOR ORAL SOLUTION, USP1172117441254127Rx only

Approved
Approval ID

2bfee83c-4f38-440e-9061-58036490d009

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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

Penicillin V Potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-1780
Application NumberANDA060456
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillin V Potassium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2012
FDA Product Classification

INGREDIENTS (5)

SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PENICILLIN V POTASSIUMActive
Quantity: 250 mg in 5 mL
Code: 146T0TU1JB
Classification: ACTIM

Penicillin V Potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4125
Application NumberANDA060456
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillin V Potassium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2012
FDA Product Classification

INGREDIENTS (5)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
PENICILLIN V POTASSIUMActive
Quantity: 125 mg in 5 mL
Code: 146T0TU1JB
Classification: ACTIM

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Penicillin V Potassium - FDA Drug Approval Details