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Penicillin V Potassium

Penicillin V Potassium Tablets, USP Rx only

Approved
Approval ID

abaf32bf-9f5f-1d07-e053-2995a90a4ea3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 26, 2020

Manufacturers
FDA

Denton Pharma, Inc. dba Northwind Pharmaceuticals

DUNS: 080355546

Products 1

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 Code70934-579
Application NumberANDA065435
Product Classification
M
Marketing Category
C73584
G
Generic Name
Penicillin V Potassium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 26, 2020
FDA Product Classification

INGREDIENTS (9)

POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PENICILLIN V POTASSIUMActive
Quantity: 250 mg in 1 1
Code: 146T0TU1JB
Classification: ACTIM

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Penicillin V Potassium - FDA Drug Approval Details