Metronidazole

Product NDC
71335-1681
11-digit product format
713351681
Labeler code
71335
Product ID
71335-1681_bf0721d6-e6ff-4afd-b09a-96fbcf8cc014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079067
Marketing category
ANDA
Marketing start
2016-12-01
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
71335-1681-02024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-12024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-22024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-32024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-42024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-52024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-62024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-72024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-82024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-92024-05-21C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-02024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-12024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-22024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-32024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-42024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-52024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-62024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-72024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-82024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet
71335-1681-92024-01-30C16284748780-11030e365-0a25-111a-e063-dadaa90a10e2METRONIDAZOLE - metronidazole tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1681-0Metronidazole40 in 1 BOTTLETABLET404
71335-1681-1Metronidazole20 in 1 BOTTLETABLET204
71335-1681-2Metronidazole30 in 1 BOTTLETABLET304
71335-1681-3Metronidazole14 in 1 BOTTLETABLET144
71335-1681-4Metronidazole56 in 1 BOTTLETABLET564
71335-1681-5Metronidazole21 in 1 BOTTLETABLET214
71335-1681-6Metronidazole4 in 1 BOTTLETABLET44
71335-1681-7Metronidazole28 in 1 BOTTLETABLET284
71335-1681-8Metronidazole100 in 1 BOTTLETABLET1004
71335-1681-9Metronidazole60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1681METRONIDAZOLE TABLET [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20241121_8522493d-0a18-49dd-8d49-bd159f6ee332.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN8522493d-0a18-49dd-8d49-bd159f6ee3324
311681metronidazole 500 MG Oral TabletSCD8522493d-0a18-49dd-8d49-bd159f6ee3324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1681-07133516810040 TABLET in 1 BOTTLE (71335-1681-0) 40 tablet2024-10-310000-00-00NoNoCurrent
71335-1681-17133516810120 TABLET in 1 BOTTLE (71335-1681-1) 20 tablet2020-08-050000-00-00NoNoCurrent
71335-1681-27133516810230 TABLET in 1 BOTTLE (71335-1681-2) 30 tablet2020-08-040000-00-00NoNoCurrent
71335-1681-37133516810314 TABLET in 1 BOTTLE (71335-1681-3) 14 tablet2020-08-050000-00-00NoNoCurrent
71335-1681-47133516810456 TABLET in 1 BOTTLE (71335-1681-4) 56 tablet2024-10-310000-00-00NoNoCurrent
71335-1681-57133516810521 TABLET in 1 BOTTLE (71335-1681-5) 21 tablet2020-08-100000-00-00NoNoCurrent
71335-1681-6713351681064 TABLET in 1 BOTTLE (71335-1681-6) 4 tablet2021-07-120000-00-00NoNoCurrent
71335-1681-77133516810728 TABLET in 1 BOTTLE (71335-1681-7) 28 tablet2020-08-310000-00-00NoNoCurrent
71335-1681-871335168108100 TABLET in 1 BOTTLE (71335-1681-8) 100 tablet2024-10-310000-00-00NoNoCurrent
71335-1681-97133516810960 TABLET in 1 BOTTLE (71335-1681-9) 60 tablet2024-10-310000-00-00NoNoCurrent