FDA.reportPublic FDA data

Metronidazole

Product NDC
68071-3039
11-digit product format
680713039
Labeler code
68071
Product ID
68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
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
68071-3039-12025-02-04C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-42025-02-04C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-62025-02-04C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-82025-02-04C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-12025-01-30C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-42025-01-30C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-62025-01-30C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP
68071-3039-82025-01-30C16284748780-12cef2736-a6b0-d83d-e063-dadaa90ab31fMetronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3039-1Metronidazole14 in 1 BOTTLETABLET, FILM COATED145
68071-3039-4Metronidazole4 in 1 BOTTLETABLET, FILM COATED45
68071-3039-6Metronidazole6 in 1 BOTTLETABLET, FILM COATED65
68071-3039-8Metronidazole8 in 1 BOTTLETABLET, FILM COATED85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3039METRONIDAZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20250206_4ab90d8e-c21f-65ac-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN4ab90d8e-c21f-65ac-e054-00144ff8d46c5
314106metronidazole 250 MG Oral TabletSCD4ab90d8e-c21f-65ac-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3039-16807130390114 TABLET, FILM COATED in 1 BOTTLE (68071-3039-1) 2017-03-14NoNoCurrent
68071-3039-4680713039044 TABLET, FILM COATED in 1 BOTTLE (68071-3039-4) 2017-03-14NoNoCurrent
68071-3039-6680713039066 TABLET, FILM COATED in 1 BOTTLE (68071-3039-6) 2017-03-14NoNoCurrent
68071-3039-8680713039088 TABLET, FILM COATED in 1 BOTTLE (68071-3039-8) 2017-03-14NoNoCurrent