Metronidazole

Basic Information

Product Name

Metronidazole

FDA Product Code

50111-333

Regulatory Information

NDC Product Code

50111-333

Application Number

ANDA070027

Marketing Category

C73584

Effective Date

February 28, 2024

Territorial Authority

USA

FDA Title

Metronidazole Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

METRONIDAZOLE

Quantity: 250 mg in 1 1

Code: 140QMO216E

Class Code: ACTIB

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

HYDROGENATED COTTONSEED OIL

Code: Z82Y2C65EA

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

Code: 140QMO216E

Metronidazole

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

CROSPOVIDONE (15 MPA.S AT 5%)

HYDROGENATED COTTONSEED OIL

SILICON DIOXIDE

Active Moieties

METRONIDAZOLE