Metronidazole

Product NDC
0591-2521
11-digit product format
005912521
Labeler code
0591
Product ID
0591-2521_24f5f9ed-5a3d-4aae-83f1-473a890a5c3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070035
Marketing category
ANDA
Marketing start
2011-11-17
Marketing end
2019-09-30
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2521-01EA - Each0591-252194f26096-e2e5-4f6f-aaac-2d2258194fbe12012-07-24
0591-2521-05EA - Each0591-2521b4d03153-f10a-4dfa-8d28-3d92ee5a11b112012-07-24
0591-2521-25EA - Each0591-252143d38b10-6454-44c1-91fb-5dde421e690312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [UNIT DOSE SERVICES]2
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNcc005dfc-efea-4760-b82d-2efcd67c2b574
314106metronidazole 250 MG Oral TabletSCDcc005dfc-efea-4760-b82d-2efcd67c2b574
314106metroNIDAZOLE 250 MG Oral TabletPSN0ff3b187-4773-1d14-e054-00144ff88e881
311681metroNIDAZOLE 500 MG Oral TabletPSN0ff3b187-4773-1d14-e054-00144ff88e881
314106metronidazole 250 MG Oral TabletSCD0ff3b187-4773-1d14-e054-00144ff88e881
311681metronidazole 500 MG Oral TabletSCD0ff3b187-4773-1d14-e054-00144ff88e881