FDA.reportPublic FDA data

METRONIDAZOLE

Product NDC
61919-499
11-digit product format
619190499
Labeler code
61919
Product ID
61919-499_f2148ade-16c3-8cb4-e053-2995a90a7ef3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA203458
Marketing category
ANDA
Marketing start
2018-03-26
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
2024-12-31
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
61919-499-212025-01-30C16284748780-19d75b9cf-e5fa-f424-e053-dadaa90a57ceMETRONIDAZOLE
61919-499-302023-01-30C16284748780-1f386c64a-45d3-0266-e053-dadaa90a7c1aMETRONIDAZOLE
61919-499-212023-01-12C16284748780-19d75b9cf-e5fa-f424-e053-dadaa90a57ceMETRONIDAZOLE
61919-499-212020-01-31C16284748780-19d75b9cf-e5fa-f424-e053-dadaa90a57ceMETRONIDAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-499-30METRONIDAZOLE30 in 1 BOTTLETABLET, FILM COATED303
61919-499-21METRONIDAZOLE21 in 1 BOTTLETABLET, FILM COATED212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-499-21EA - Each61919-4999bb8ef0f-fd6f-42e8-8d74-4f371d06c54412018-05-09
61919-499-30EA - Each61919-499b83ae092-6a7d-4d4c-bd39-a17f640ab1b012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-499METRONIDAZOLE TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 1 package rows20210108_9141e5b4-f5fc-bc71-e053-2a95a90aa138.zip
61919-499METRONIDAZOLE TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20230113_6851b2c8-86d0-21c3-e053-2a91aa0ae64d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSN9141e5b4-f5fc-bc71-e053-2a95a90aa1383
314106metronidazole 250 MG Oral TabletSCD9141e5b4-f5fc-bc71-e053-2a95a90aa1383
314106metroNIDAZOLE 250 MG Oral TabletPSN6851b2c8-86d0-21c3-e053-2a91aa0ae64d2
314106metronidazole 250 MG Oral TabletSCD6851b2c8-86d0-21c3-e053-2a91aa0ae64d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-499-216191904992121 TABLET, FILM COATED in 1 BOTTLE (61919-499-21) 2018-03-260000-00-00NoNoCurrent
61919-499-306191904993030 TABLET, FILM COATED in 1 BOTTLE (61919-499-30) 2019-08-290000-00-00NoNoCurrent