Metronidazole

Product NDC
62332-630
11-digit product format
623320630
Labeler code
62332
Product ID
62332-630_c833efe6-b764-45f1-b1e9-5a250bce29c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metronidazole
Dosage form
GEL
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA212646
Marketing category
ANDA
Marketing start
2021-09-06
Substance
METRONIDAZOLE
Active strength
10 mg/g
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
METRONIDAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii140QMO216E
Rxcui577237

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
62332-630-45Metronidazole45 g in 1 TUBEGEL457
62332-630-45Metronidazole1 in 1 CARTONGEL17
62332-630-55Metronidazole55 g in 1 BOTTLE, PUMPGEL557
62332-630-55Metronidazole1 in 1 CARTONGEL17
62332-630-60Metronidazole1 in 1 CARTONGEL17
62332-630-60Metronidazole60 g in 1 TUBEGEL607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-630-55GM - Gram62332-630a767b3f7-0bbf-45d1-a515-1c8024f9438d12021-12-08
62332-630-60GM - Gram62332-6301e6dabed-ff04-47ef-85b6-9c0248e4f17b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-630METRONIDAZOLE GEL [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 6 package rows20240306_9f56cc00-6383-48c8-95ee-e6a404a0237b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577237metroNIDAZOLE 1 % Topical GelPSN9f56cc00-6383-48c8-95ee-e6a404a0237b7
577237metronidazole 0.01 MG/MG Topical GelSCD9f56cc00-6383-48c8-95ee-e6a404a0237b7
577237metronidazole 1 % Topical GelSY9f56cc00-6383-48c8-95ee-e6a404a0237b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-630-45623320630451 TUBE in 1 CARTON (62332-630-45) / 45 g in 1 TUBE1 tube2021-09-060000-00-00NoNoCurrent
62332-630-55623320630551 BOTTLE, PUMP in 1 CARTON (62332-630-55) / 55 g in 1 BOTTLE, PUMP2021-09-060000-00-00NoNoCurrent
62332-630-60623320630601 TUBE in 1 CARTON (62332-630-60) / 60 g in 1 TUBE1 tube2021-09-060000-00-00NoNoCurrent