FDA.reportPublic FDA data

metronidazole

Product NDC
70934-801
11-digit product format
709340801
Labeler code
70934
Product ID
70934-801_b725cba6-5cab-0c25-e053-2995a90ae2c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA070772
Marketing category
ANDA
Marketing start
2020-11-04
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
2021-12-31
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
70934-801-142022-01-28C16284748780-1d6a99b39-9aa1-a426-e053-dadaa90af4c2Metronidazole Tablets, USP Rx Only
70934-801-212022-01-28C16284748780-1d6a99b39-9aa1-a426-e053-dadaa90af4c2Metronidazole Tablets, USP Rx Only
70934-801-302022-01-28C16284748780-1d6a99b39-9aa1-a426-e053-dadaa90af4c2Metronidazole Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-801-14metronidazole14 in 1 BOTTLE, PLASTICTABLET142
70934-801-21metronidazole21 in 1 BOTTLE, PLASTICTABLET212
70934-801-30metronidazole30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-801METRONIDAZOLE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 3 package rows20201224_b558d620-fb67-16eb-e053-2995a90a04fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNb558d620-fb67-16eb-e053-2995a90a04fe2
311681metronidazole 500 MG Oral TabletSCDb558d620-fb67-16eb-e053-2995a90a04fe2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-801-147093408011414 TABLET in 1 BOTTLE, PLASTIC (70934-801-14) 14 tablet2020-12-040000-00-00NoNoCurrent
70934-801-217093408012121 TABLET in 1 BOTTLE, PLASTIC (70934-801-21) 21 tablet2020-11-040000-00-00NoNoCurrent
70934-801-307093408013030 TABLET in 1 BOTTLE, PLASTIC (70934-801-30) 30 tablet2020-11-040000-00-00NoNoCurrent