FDA.reportPublic FDA data

Metronidazole

Product NDC
12634-172
11-digit product format
126340172
Labeler code
12634
Product ID
12634-172_2783e34b-384e-04af-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA203458
Marketing category
ANDA
Marketing start
2014-06-01
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
2019-12-31
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
12634-172-002020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-012020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-482020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-502020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-712020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-782020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-792020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-802020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-812020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-842020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-942020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP
12634-172-992020-01-31C16284748780-19d75b9d1-0324-f424-e053-dadaa90a57ceMetronidazole Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-172-00Metronidazole10 in 1 BOTTLETABLET, FILM COATED102
12634-172-01Metronidazole100 in 1 BOTTLETABLET, FILM COATED1002
12634-172-48Metronidazole21 in 1 BLISTER PACKTABLET, FILM COATED212
12634-172-50Metronidazole50 in 1 BOTTLETABLET, FILM COATED502
12634-172-71Metronidazole30 in 1 BOTTLETABLET, FILM COATED302
12634-172-78Metronidazole28 in 1 BOTTLETABLET, FILM COATED282
12634-172-79Metronidazole25 in 1 BOTTLETABLET, FILM COATED252
12634-172-80Metronidazole20 in 1 BOTTLETABLET, FILM COATED202
12634-172-81Metronidazole21 in 1 BOTTLETABLET, FILM COATED212
12634-172-84Metronidazole14 in 1 BOTTLETABLET, FILM COATED142
12634-172-94Metronidazole4 in 1 BOTTLETABLET, FILM COATED42
12634-172-99Metronidazole9 in 1 BOTTLETABLET, FILM COATED92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-172METRONIDAZOLE TABLET, FILM COATED [APOTHECA INC.]2Legacy NDC, 12 package rows20151223_2783e34b-384d-04af-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN2783e34b-384d-04af-e054-00144ff8d46c2
311681metronidazole 500 MG Oral TabletSCD2783e34b-384d-04af-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-172-001263401720010 in 1 BOTTLEHistorical
12634-172-0112634017201100 in 1 BOTTLEHistorical
12634-172-481263401724821 in 1 BLISTER PACKHistorical
12634-172-501263401725050 in 1 BOTTLEHistorical
12634-172-711263401727130 in 1 BOTTLEHistorical
12634-172-781263401727828 in 1 BOTTLEHistorical
12634-172-791263401727925 in 1 BOTTLEHistorical
12634-172-801263401728020 in 1 BOTTLEHistorical
12634-172-811263401728121 in 1 BOTTLEHistorical
12634-172-841263401728414 in 1 BOTTLEHistorical
12634-172-94126340172944 in 1 BOTTLEHistorical
12634-172-99126340172999 in 1 BOTTLEHistorical