FDA.reportPublic FDA data

Metronidazole

Product NDC
61919-788
11-digit product format
619190788
Labeler code
61919
Product ID
61919-788_9c993b09-f434-430f-e053-2995a90ace6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA079067
Marketing category
ANDA
Marketing start
2015-01-01
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
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
61919-788-042023-01-30C16284748780-1f386c649-c4d9-0266-e053-dadaa90a7c1aMetronidazole
61919-788-102023-01-30C16284748780-1f386c649-c4d9-0266-e053-dadaa90a7c1aMetronidazole
61919-788-142023-01-30C16284748780-1f386c649-c4d9-0266-e053-dadaa90a7c1aMetronidazole
61919-788-202023-01-30C16284748780-1f386c649-c4d9-0266-e053-dadaa90a7c1aMetronidazole
61919-788-302023-01-30C16284748780-1f386c649-c4d9-0266-e053-dadaa90a7c1aMetronidazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-788-04Metronidazole4 in 1 BOTTLETABLET46
61919-788-10Metronidazole10 in 1 BOTTLETABLET106
61919-788-14Metronidazole14 in 1 BOTTLETABLET146
61919-788-20Metronidazole20 in 1 BOTTLETABLET206
61919-788-30Metronidazole30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-788-30EA - Each61919-788ab4877cb-f930-43d0-84c4-a8b217d9b92112016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]4
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [DIRECT RX]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [DIRECT RX]4
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [DIRECT RX]4
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTMETRONIDAZOLE TABLET [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-788METRONIDAZOLE TABLET [DIRECT RX]6Legacy NDC, 5 package rows20200121_7a16cc16-9fde-4943-bf4f-f6c9435963bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311681metroNIDAZOLE 500 MG Oral TabletPSN7a16cc16-9fde-4943-bf4f-f6c9435963bf6
311681metronidazole 500 MG Oral TabletSCD7a16cc16-9fde-4943-bf4f-f6c9435963bf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-788-04619190788044 TABLET in 1 BOTTLE (61919-788-04) 4 tablet2015-01-010000-00-00NoNoCurrent
61919-788-106191907881010 TABLET in 1 BOTTLE (61919-788-10) 10 tablet2015-01-010000-00-00NoNoCurrent
61919-788-146191907881414 TABLET in 1 BOTTLE (61919-788-14) 14 tablet2015-01-010000-00-00NoNoCurrent
61919-788-206191907882020 TABLET in 1 BOTTLE (61919-788-20) 20 tablet2015-01-010000-00-00NoNoCurrent
61919-788-306191907883030 TABLET in 1 BOTTLE (61919-788-30) 30 tablet2015-01-010000-00-00NoNoCurrent