FDA.reportPublic FDA data

Flagyl

Product NDC
0025-1821
11-digit product format
000251821
Labeler code
0025
Product ID
0025-1821_02928f32-a562-426c-8d53-f4b94006d50c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA012623
Marketing category
NDA
Marketing start
1963-07-18
Marketing end
2021-10-31
Substance
METRONIDAZOLE
Active strength
500 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0025-1821DDiscontinued by firm2026-07-31
excluded packagepackage0025-18210025-1821-31DDiscontinued by firm2026-07-31
excluded packagepackage0025-18210025-1821-50DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012623-001FLAGYLMETRONIDAZOLE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N012623-003FLAGYLMETRONIDAZOLE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N012623-001FLAGYL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N012623-003FLAGYL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-1821-31EA - Each0025-18215bacfdad-608d-4107-bd78-7f414b313a3912012-07-24
0025-1821-50EA - Each0025-1821f1131527-fe58-4d51-9938-ae3654ef1ce512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
METRONIDAZOLEACTIVE MOIETY140QMO216EFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLAGYL (METRONIDAZOLE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0025-1821-3100025182131100 TABLET, FILM COATED in 1 BOTTLE (0025-1821-31) 1963-07-182021-10-31NoNoCurrent
0025-1821-500002518215050 TABLET, FILM COATED in 1 BOTTLE (0025-1821-50) 1963-07-182021-10-31NoNoCurrent