Penicillin V Potasium

Basic Information

Product Name

FDA Product Code

53217-290

Regulatory Information

NDC Product Code

53217-290

Application Number

ANDA064071

Marketing Category

C73584

Effective Date

May 11, 2017

Territorial Authority

USA

FDA Title

Penicillin-VK Penicillin V Potassium Tablets, USP 250 mg (400,000 Units ) 500 mg (800,000 Units)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOLS

Code: 3WJQ0SDW1A

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

PENICILLIN V POTASSIUM

Quantity: 500 mg in 1 1

Code: 146T0TU1JB

Class Code: ACTIM

Active Moieties

PENICILLIN V

Code: Z61I075U2W

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSES

MAGNESIUM STEARATE

POLYETHYLENE GLYCOLS

POVIDONE

TITANIUM DIOXIDE

TALC

Active Moieties

PENICILLIN V