Home NDC 0025-1831 Flagyl
Product NDC 0025-1831
11-digit product format 000251831
Labeler code 0025
Product ID 0025-1831_1cd7701c-551e-4564-b8d4-0ec1b15e5069
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler G.D. Searle LLC Division of Pfizer Inc
Application NDA012623
Marketing category NDA
Marketing start 1963-07-18
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 250 mg/1
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012623-001 FLAGYL METRONIDAZOLE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N012623-003 FLAGYL METRONIDAZOLE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982
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 N012623-001 FLAGYL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-08-01 22:54:32 2026-06 N012623-003 FLAGYL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 METRONIDAZOLE ACTIVE MOIETY 140QMO216E FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10