FDA.reportPublic FDA data

Metronidazole

Product NDC
21695-308
11-digit product format
216950308
Labeler code
21695
Product ID
21695-308_e8782624-2e60-4fd3-ba49-bf51d314676b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA070027
Marketing category
ANDA
Marketing start
2010-09-01
Marketing end
0000-00-00
Substance
METRONIDAZOLE
Active strength
250 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
21695-308-212019-09-24C16284748780-1934fe258-4806-48b1-e053-8cdaa90a720aMETRONIDAZOLE TABLETS USP
21695-308-282019-09-24C16284748780-1934fe258-4806-48b1-e053-8cdaa90a720aMETRONIDAZOLE TABLETS USP
21695-308-302019-09-24C16284748780-1934fe258-4806-48b1-e053-8cdaa90a720aMETRONIDAZOLE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-308-21Metronidazole21 in 1 BOTTLETABLET214
21695-308-28Metronidazole28 in 1 BOTTLETABLET284
21695-308-30Metronidazole30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-308-21EA - Each21695-3084013970c-6f7e-4adc-8143-90fcda77ee0d12012-07-24
21695-308-28EA - Each21695-308291b38b5-dd24-4ebb-a7a2-08e490a8034512012-07-24
21695-308-30EA - Each21695-308b4098ac9-9861-4bfb-b952-24f9012c81e512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-308METRONIDAZOLE TABLET [REBEL DISTRIBUTORS CORP]4Legacy NDC, 3 package rows20120511_a775da83-6554-4229-afb8-92cdcfb4503e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNa775da83-6554-4229-afb8-92cdcfb4503e4
311681metroNIDAZOLE 500 MG Oral TabletPSNa775da83-6554-4229-afb8-92cdcfb4503e4
314106metronidazole 250 MG Oral TabletSCDa775da83-6554-4229-afb8-92cdcfb4503e4
311681metronidazole 500 MG Oral TabletSCDa775da83-6554-4229-afb8-92cdcfb4503e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-308-212169503082121 in 1 BOTTLEHistorical
21695-308-282169503082828 in 1 BOTTLEHistorical
21695-308-302169503083030 in 1 BOTTLEHistorical