Metronidazole

Product NDC
68071-2343
11-digit product format
680712343
Labeler code
68071
Product ID
68071-2343_ba739cf8-4823-46e6-e053-2995a90ae7bf
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
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
68071-2343-02025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-12025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-22025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-32025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-42025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-52025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-72025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-82025-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-12023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-22023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-32023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-42023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-52023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-72023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-82023-09-22C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-12023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-22023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-32023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-42023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-52023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-72023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only
68071-2343-82023-01-30C16284748780-1f386c64a-251d-0266-e053-dadaa90a7c1aMetronidazole Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2343-0Metronidazole42 in 1 BOTTLETABLET422
68071-2343-1Metronidazole4 in 1 BOTTLETABLET42
68071-2343-2Metronidazole21 in 1 BOTTLETABLET212
68071-2343-3Metronidazole30 in 1 BOTTLETABLET302
68071-2343-4Metronidazole14 in 1 BOTTLETABLET142
68071-2343-5Metronidazole40 in 1 BOTTLETABLET402
68071-2343-7Metronidazole20 in 1 BOTTLETABLET202
68071-2343-8Metronidazole28 in 1 BOTTLETABLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2343METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 8 package rows20230923_ba73a050-9a5c-1549-e053-2a95a90a62aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNba73a050-9a5c-1549-e053-2a95a90a62aa2
311681metronidazole 500 MG Oral TabletSCDba73a050-9a5c-1549-e053-2a95a90a62aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2343-06807123430042 in 1 BOTTLEHistorical
68071-2343-1680712343014 TABLET in 1 BOTTLE (68071-2343-1) 4 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-26807123430221 TABLET in 1 BOTTLE (68071-2343-2) 21 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-36807123430330 TABLET in 1 BOTTLE (68071-2343-3) 30 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-46807123430414 TABLET in 1 BOTTLE (68071-2343-4) 14 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-56807123430540 TABLET in 1 BOTTLE (68071-2343-5) 40 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-76807123430720 TABLET in 1 BOTTLE (68071-2343-7) 20 tablet2021-02-030000-00-00NoNoCurrent
68071-2343-86807123430828 TABLET in 1 BOTTLE (68071-2343-8) 28 tablet2021-02-030000-00-00NoNoCurrent