FDA.reportPublic FDA data

Metronidazole

Product NDC
63629-7916
11-digit product format
636297916
Labeler code
63629
Product ID
63629-7916_1d6e2095-0b00-4773-ac12-06c7aef3ecc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55Product name520251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17Product name120250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1Product name520250515
e1aac33b-94ae-4ee9-905b-299f7263853bProduct name320250124
16642716-d28a-4f90-8dcb-3921cd8c8109Product name420240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
0add4de9-d152-3375-3390-1123dddc5e3dProduct name120140508
33ca0fcc-1011-92dc-50a9-a383683eed1eProduct name120140508
53f39d9f-cd3f-04e1-c668-d4580719d57dProduct name120140508
a804000f-b74f-0b5d-d17b-aa767c286ddbProduct name120140508
a91ea265-6e02-c08f-93c8-686d54180529Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7916-12024-05-15C16284748780-11030e365-6005-111a-e063-dadaa90a10e2Metronidazole Tablets USP
63629-7916-12024-01-30C16284748780-11030e365-6005-111a-e063-dadaa90a10e2Metronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7916-1Metronidazole14 in 1 BOTTLETABLET, FILM COATED146
63629-7916-2Metronidazole3 in 1 BOTTLETABLET, FILM COATED36
63629-7916-3Metronidazole9 in 1 BOTTLETABLET, FILM COATED96
63629-7916-4Metronidazole10 in 1 BOTTLETABLET, FILM COATED106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN1abb2827-67e4-43c0-9762-8261f480fc3a6
311681metronidazole 500 MG Oral TabletSCD1abb2827-67e4-43c0-9762-8261f480fc3a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7916-16362979160114 TABLET, FILM COATED in 1 BOTTLE (63629-7916-1) 2025-06-190000-00-00NoNoCurrent
63629-7916-2636297916023 TABLET, FILM COATED in 1 BOTTLE (63629-7916-2) 2025-06-19NoNoHistorical
63629-7916-3636297916039 TABLET, FILM COATED in 1 BOTTLE (63629-7916-3) 2025-06-19NoNoHistorical
63629-7916-46362979160410 TABLET, FILM COATED in 1 BOTTLE (63629-7916-4) 2025-06-19NoNoHistorical