FDA.reportPublic FDA data

metronidazole

Product NDC
68071-2409
11-digit product format
680712409
Labeler code
68071
Product ID
68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206560
Marketing category
ANDA
Marketing start
2019-02-23
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
a5070875-62bb-61e1-fd46-8f7054197a40Product name820180215
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2409-12024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-22024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-32024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-42024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-52024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-72024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-82024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-92024-02-09C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-12023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-22023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-32023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-42023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-52023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-72023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-82023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only
68071-2409-92023-01-30C16284748780-1f386c64a-1fd9-0266-e053-dadaa90a7c1aMetronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2409-1metronidazole4 in 1 BOTTLETABLET42
68071-2409-2metronidazole21 in 1 BOTTLETABLET212
68071-2409-3metronidazole30 in 1 BOTTLETABLET302
68071-2409-4metronidazole14 in 1 BOTTLETABLET142
68071-2409-5metronidazole40 in 1 BOTTLETABLET402
68071-2409-7metronidazole20 in 1 BOTTLETABLET202
68071-2409-8metronidazole28 in 1 BOTTLETABLET282
68071-2409-9metronidazole90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2409METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 8 package rows20240210_c2dbfec8-da5b-cd2b-e053-2a95a90ad17c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNc2dbfec8-da5b-cd2b-e053-2a95a90ad17c2
311681metronidazole 500 MG Oral TabletSCDc2dbfec8-da5b-cd2b-e053-2a95a90ad17c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2409-1680712409014 TABLET in 1 BOTTLE (68071-2409-1) 4 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-26807124090221 TABLET in 1 BOTTLE (68071-2409-2) 21 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-36807124090330 TABLET in 1 BOTTLE (68071-2409-3) 30 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-46807124090414 TABLET in 1 BOTTLE (68071-2409-4) 14 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-56807124090540 TABLET in 1 BOTTLE (68071-2409-5) 40 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-76807124090720 TABLET in 1 BOTTLE (68071-2409-7) 20 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-86807124090828 TABLET in 1 BOTTLE (68071-2409-8) 28 tablet2021-05-210000-00-00NoNoCurrent
68071-2409-96807124090990 TABLET in 1 BOTTLE (68071-2409-9) 90 tablet2021-05-210000-00-00NoNoCurrent