FDA.reportPublic FDA data

Metronidazole

Product NDC
62332-018
11-digit product format
623320018
Labeler code
62332
Product ID
62332-018_ace1651e-8d41-43b4-bdd2-611321f2e137
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metronidazole
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA079065
Marketing category
ANDA
Marketing start
2016-12-09
Substance
METRONIDAZOLE
Active strength
375 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
METRONIDAZOLE375 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui199055

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
62332-018-30Metronidazole30 in 1 BOTTLECAPSULE3013
62332-018-31Metronidazole100 in 1 BOTTLECAPSULE10013
62332-018-50Metronidazole50 in 1 BOTTLECAPSULE5013
62332-018-71Metronidazole500 in 1 BOTTLECAPSULE50013
62332-018-91Metronidazole1000 in 1 BOTTLECAPSULE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-018-50EA - Each62332-01803febebc-7537-4edf-97a1-fccbc9cfde7912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-018METRONIDAZOLE CAPSULE [ALEMBIC PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 5 package rows20250302_f9b4c86c-932b-4b43-ab1a-6d9e07958044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199055metroNIDAZOLE 375 MG Oral CapsulePSNf9b4c86c-932b-4b43-ab1a-6d9e0795804413
199055metronidazole 375 MG Oral CapsuleSCDf9b4c86c-932b-4b43-ab1a-6d9e0795804413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-018-306233200183030 CAPSULE in 1 BOTTLE (62332-018-30) 30 capsule2016-12-090000-00-00NoNoCurrent
62332-018-3162332001831100 CAPSULE in 1 BOTTLE (62332-018-31) 100 capsule2016-12-090000-00-00NoNoCurrent
62332-018-506233200185050 CAPSULE in 1 BOTTLE (62332-018-50) 50 capsule2016-12-090000-00-00NoNoCurrent
62332-018-7162332001871500 CAPSULE in 1 BOTTLE (62332-018-71) 500 capsule2016-12-090000-00-00NoNoCurrent
62332-018-91623320018911000 CAPSULE in 1 BOTTLE (62332-018-91) 1000 capsule2016-12-090000-00-00NoNoCurrent