Home NDC 0591-2521 Metronidazole
Product NDC 0591-2521
11-digit product format 005912521
Labeler code 0591
Product ID 0591-2521_24f5f9ed-5a3d-4aae-83f1-473a890a5c3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA070035
Marketing category ANDA
Marketing start 2011-11-17
Marketing end 2019-09-30
Substance METRONIDAZOLE
Active strength 250 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A070035-001 METRONIDAZOLE METRONIDAZOLE 250MG TABLET / ORAL AB 1984-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070035-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A070035-001 METRONIDAZOLE 250MG TABLET / ORAL AB 1984-12-20 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A070035-001 AB 1 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METRONIDAZOLE TABLET [ACTAVIS PHARMA, INC.] 11 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METRONIDAZOLE TABLET [UNIT DOSE SERVICES] 2 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METRONIDAZOLE TABLET [AMERICAN HEALTH PACKAGING] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.] 1
DailyMed RxNorm Mappings#