FDA.reportPublic FDA data

Metronidazole

Product NDC
68071-2399
11-digit product format
680712399
Labeler code
68071
Product ID
68071-2399_4cecacbc-1f33-c0b5-e063-6394a90aeb33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203974
Marketing category
ANDA
Marketing start
2015-05-29
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2027-12-31

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
68071-2399-42023-01-30C16284748780-1f386c64a-12f9-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2399-62023-01-30C16284748780-1f386c64a-12f9-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2399-4Metronidazole4 in 1 BOTTLETABLET42
68071-2399-6Metronidazole6 in 1 BOTTLETABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2399METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, Legacy NDC, 2 package rows20210513_c225a455-ec25-2213-e053-2995a90a3389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNc225a455-ec25-2213-e053-2995a90a33892
311681metronidazole 500 MG Oral TabletSCDc225a455-ec25-2213-e053-2995a90a33892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2399-4680712399044 TABLET in 1 BOTTLE (68071-2399-4) 4 tablet2021-05-120000-00-00NoNoCurrent
68071-2399-6680712399066 TABLET in 1 BOTTLE (68071-2399-6) 6 tablet2021-05-120000-00-00NoNoCurrent