FDA.reportPublic FDA data

METRONIDAZOLE

Product NDC
61919-363
11-digit product format
619190363
Labeler code
61919
Product ID
61919-363_f212fdf7-7cb3-ed89-e053-2a95a90ac688
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METRONIDAZOLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA070044
Marketing category
ANDA
Marketing start
2018-03-14
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
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
61919-363-302025-01-30C16284748780-12cef2736-a1ea-d83d-e063-dadaa90ab31fMETRONIDAZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-363-30METRONIDAZOLE30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-363-30EA - Each61919-363eae731f5-1ca2-4e76-a04d-9809e1f7b86012018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [DIRECT RX]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-363METRONIDAZOLE TABLET, FILM COATED [DIRECT RX]6Legacy NDC, 1 package rows20230113_fb306ef2-5203-4034-b699-b8657c7ef257.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSNfb306ef2-5203-4034-b699-b8657c7ef2576
311681metronidazole 500 MG Oral TabletSCDfb306ef2-5203-4034-b699-b8657c7ef2576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-363-306191903633030 TABLET, FILM COATED in 1 BOTTLE (61919-363-30) 2018-03-140000-00-00NoNoCurrent