FDA.reportPublic FDA data

Metronidazole

Product NDC
62332-016
11-digit product format
623320016
Labeler code
62332
Product ID
62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA079067
Marketing category
ANDA
Marketing start
2016-12-01
Substance
METRONIDAZOLE
Active strength
250 mg/1
Pharmacologic classes
Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metronidazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METRONIDAZOLE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui311681, 314106

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-016-30Metronidazole30 in 1 BOTTLETABLET3015
62332-016-31Metronidazole100 in 1 BOTTLETABLET10015
62332-016-50Metronidazole50 in 1 BOTTLETABLET5015
62332-016-61Metronidazole250 in 1 BOTTLETABLET25015
62332-016-71Metronidazole500 in 1 BOTTLETABLET50015
62332-016-91Metronidazole1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-016-31EA - Each62332-0163a871ab9-eb2f-48f1-a9be-bdf2458601ef12017-03-06
62332-016-71EA - Each62332-016c055a412-f2c7-4396-89c2-a1993aefc54e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-016METRONIDAZOLE TABLET [ALEMBIC PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 6 package rows20241009_b1fcf023-cdfd-45b7-b4d4-ff814f33ee79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314106metroNIDAZOLE 250 MG Oral TabletPSNb1fcf023-cdfd-45b7-b4d4-ff814f33ee7915
311681metroNIDAZOLE 500 MG Oral TabletPSNb1fcf023-cdfd-45b7-b4d4-ff814f33ee7915
314106metronidazole 250 MG Oral TabletSCDb1fcf023-cdfd-45b7-b4d4-ff814f33ee7915
311681metronidazole 500 MG Oral TabletSCDb1fcf023-cdfd-45b7-b4d4-ff814f33ee7915
314106metroNIDAZOLE 250 MG Oral TabletPSN9623181f-5e3b-3695-e053-2a95a90a99f64
311681metroNIDAZOLE 500 MG Oral TabletPSN9623181f-5e3b-3695-e053-2a95a90a99f64
314106metronidazole 250 MG Oral TabletSCD9623181f-5e3b-3695-e053-2a95a90a99f64
311681metronidazole 500 MG Oral TabletSCD9623181f-5e3b-3695-e053-2a95a90a99f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-016-306233200163030 TABLET in 1 BOTTLE (62332-016-30) 30 tablet2016-12-010000-00-00NoNoCurrent
62332-016-3162332001631100 TABLET in 1 BOTTLE (62332-016-31) 100 tablet2016-12-010000-00-00NoNoCurrent
62332-016-506233200165050 TABLET in 1 BOTTLE (62332-016-50) 50 tablet2016-12-010000-00-00NoNoCurrent
62332-016-6162332001661250 TABLET in 1 BOTTLE (62332-016-61) 250 tablet2016-12-010000-00-00NoNoCurrent
62332-016-7162332001671500 TABLET in 1 BOTTLE (62332-016-71) 500 tablet2016-12-010000-00-00NoNoCurrent
62332-016-91623320016911000 TABLET in 1 BOTTLE (62332-016-91) 1000 tablet2016-12-010000-00-00NoNoCurrent