Penicillin V Potassium
Penicillin V Potassium Tablets, USP Rx only
Approved
Approval ID
ec25ce45-c0b2-45fa-9211-77f283aad4bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 28, 2022
Manufacturers
FDA
NorthStar Rx LLC
DUNS: 830546433
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
NDC Product Code16714-234
Application NumberANDA065435
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2022
Generic NamePenicillin V Potassium
INGREDIENTS (9)
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
Penicillin V Potassium
PRODUCT DETAILS
NDC Product Code16714-235
Application NumberANDA065435
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 28, 2022
Generic NamePenicillin V Potassium
INGREDIENTS (9)
PENICILLIN V POTASSIUMActive
Quantity: 500 mg in 1 1
Code: 146T0TU1JB
Classification: ACTIM
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT