FDA.reportPublic FDA data

Metronidazole

Product NDC
71335-0858
11-digit product format
713350858
Labeler code
71335
Product ID
71335-0858_ac72621d-0d70-448b-b53c-903c6fdb7ee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070027
Marketing category
ANDA
Marketing start
1990-09-30
Substance
METRONIDAZOLE
Active strength
250 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
METRONIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui314106

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
71335-0858-02024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-12024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-22024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-32024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-42024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-52024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-62024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-72024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-82024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-92024-05-16C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-02024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-12024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-22024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-32024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-42024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-52024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-62024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-72024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-82024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP
71335-0858-92024-01-30C16284748780-11030e365-3f65-111a-e063-dadaa90a10e2Metronidazole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0858-0Metronidazole7 in 1 BOTTLETABLET76
71335-0858-1Metronidazole21 in 1 BOTTLETABLET216
71335-0858-2Metronidazole30 in 1 BOTTLETABLET306
71335-0858-3Metronidazole20 in 1 BOTTLETABLET206
71335-0858-4Metronidazole60 in 1 BOTTLETABLET606
71335-0858-5Metronidazole28 in 1 BOTTLETABLET286
71335-0858-6Metronidazole14 in 1 BOTTLETABLET146
71335-0858-7Metronidazole40 in 1 BOTTLETABLET406
71335-0858-8Metronidazole42 in 1 BOTTLETABLET426
71335-0858-9Metronidazole56 in 1 BOTTLETABLET566

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0858METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240823_ea635d05-b3c1-4f49-ace2-d091c20920da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNea635d05-b3c1-4f49-ace2-d091c20920da6
314106metronidazole 250 MG Oral TabletSCDea635d05-b3c1-4f49-ace2-d091c20920da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0858-0713350858007 TABLET in 1 BOTTLE (71335-0858-0) 7 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-17133508580121 TABLET in 1 BOTTLE (71335-0858-1) 21 tablet2019-05-130000-00-00NoNoCurrent
71335-0858-27133508580230 TABLET in 1 BOTTLE (71335-0858-2) 30 tablet2019-12-260000-00-00NoNoCurrent
71335-0858-37133508580320 TABLET in 1 BOTTLE (71335-0858-3) 20 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-47133508580460 TABLET in 1 BOTTLE (71335-0858-4) 60 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-57133508580528 TABLET in 1 BOTTLE (71335-0858-5) 28 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-67133508580614 TABLET in 1 BOTTLE (71335-0858-6) 14 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-77133508580740 TABLET in 1 BOTTLE (71335-0858-7) 40 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-87133508580842 TABLET in 1 BOTTLE (71335-0858-8) 42 tablet2024-08-090000-00-00NoNoCurrent
71335-0858-97133508580956 TABLET in 1 BOTTLE (71335-0858-9) 56 tablet2018-08-060000-00-00NoNoCurrent