Metronidazole

Product NDC
53002-2471
11-digit product format
530022471
Labeler code
53002
Product ID
53002-2471_282eb907-1e6c-48ea-a3b6-2e7fe9b1bcff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
RPK 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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2471-1Metronidazole10 in 1 BOTTLETABLET101
53002-2471-2Metronidazole14 in 1 BOTTLETABLET141
53002-2471-3Metronidazole20 in 1 BOTTLETABLET201
53002-2471-4Metronidazole28 in 1 BOTTLETABLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2471METRONIDAZOLE TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 4 package rows20220331_8ed090d4-363f-4e67-8ccd-e8c74a32e209.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN8ed090d4-363f-4e67-8ccd-e8c74a32e2091
311681metronidazole 500 MG Oral TabletSCD8ed090d4-363f-4e67-8ccd-e8c74a32e2091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2471-15300224710110 TABLET in 1 BOTTLE (53002-2471-1) 10 tablet2021-01-010000-00-00NoNoCurrent
53002-2471-25300224710214 TABLET in 1 BOTTLE (53002-2471-2) 14 tablet2021-01-010000-00-00NoNoCurrent
53002-2471-35300224710320 TABLET in 1 BOTTLE (53002-2471-3) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-2471-45300224710428 TABLET in 1 BOTTLE (53002-2471-4) 28 tablet2021-01-010000-00-00NoNoCurrent