metronidazole

Product NDC
68071-2549
11-digit product format
680712549
Labeler code
68071
Product ID
68071-2549_cddb7b20-9308-5ad6-e053-2995a90a3a3d
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
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
250 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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2549-1metronidazole14 in 1 BOTTLETABLET142
68071-2549-2metronidazole21 in 1 BOTTLETABLET212
68071-2549-3metronidazole30 in 1 BOTTLETABLET302
68071-2549-8metronidazole28 in 1 BOTTLETABLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2549METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 4 package rows20230718_cddb5d3c-bd27-8589-e053-2995a90ad1e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNcddb5d3c-bd27-8589-e053-2995a90ad1e32
314106metronidazole 250 MG Oral TabletSCDcddb5d3c-bd27-8589-e053-2995a90ad1e32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2549-16807125490114 TABLET in 1 BOTTLE (68071-2549-1) 14 tablet2021-10-080000-00-00NoNoCurrent
68071-2549-26807125490221 TABLET in 1 BOTTLE (68071-2549-2) 21 tablet2021-10-080000-00-00NoNoCurrent
68071-2549-36807125490330 TABLET in 1 BOTTLE (68071-2549-3) 30 tablet2021-10-080000-00-00NoNoCurrent
68071-2549-86807125490828 TABLET in 1 BOTTLE (68071-2549-8) 28 tablet2021-10-080000-00-00NoNoCurrent