Metronidazole

Product NDC
10544-265
11-digit product format
105440265
Labeler code
10544
Product ID
10544-265_2f319de6-79f0-454a-b9f8-9f9049ae898f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA070033
Marketing category
ANDA
Marketing start
2010-04-14
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
500 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-265-042020-01-31C16284748780-19d75b9cf-d136-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP
10544-265-142020-01-31C16284748780-19d75b9cf-d136-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP
10544-265-202020-01-31C16284748780-19d75b9cf-d136-f424-e053-dadaa90a57ceMETRONIDAZOLE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-265-04Metronidazole04 in 1 BOTTLETABLET042
10544-265-14Metronidazole14 in 1 BOTTLETABLET142
10544-265-20Metronidazole20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-265METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 3 package rows20151228_6d969bc3-8182-4b4b-862e-3fb6a5cfc04f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN6d969bc3-8182-4b4b-862e-3fb6a5cfc04f2
311681metronidazole 500 MG Oral TabletSCD6d969bc3-8182-4b4b-862e-3fb6a5cfc04f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-265-041054402650404 in 1 BOTTLEHistorical
10544-265-141054402651414 in 1 BOTTLEHistorical
10544-265-201054402652020 in 1 BOTTLEHistorical