Albendazole

Product NDC
62332-681
11-digit product format
623320681
Labeler code
62332
Product ID
62332-681_1b130bfa-78ff-40d2-8612-90e7133d2379
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215652
Marketing category
ANDA
Marketing start
2024-09-11
Substance
ALBENDAZOLE
Active strength
200 mg/1
Pharmacologic classes
Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBENDAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF4216019LN
Rxcui199672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0e27303-91cd-2fd1-e9ec-fbe22a3c3f49Product name820250325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-681-02Albendazole2 in 1 BOTTLETABLET, FILM COATED22
62332-681-28Albendazole28 in 1 BOTTLETABLET, FILM COATED282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-681ALBENDAZOLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]2Current NDC, 2 package rows20240918_2d6856a3-583e-41d4-b73d-6867cbb9778c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN2d6856a3-583e-41d4-b73d-6867cbb9778c2
199672albendazole 200 MG Oral TabletSCD2d6856a3-583e-41d4-b73d-6867cbb9778c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-681-02623320681022 TABLET, FILM COATED in 1 BOTTLE (62332-681-02) 2024-09-11NoNoHistorical
62332-681-286233206812828 TABLET, FILM COATED in 1 BOTTLE (62332-681-28) 2024-09-11NoNoHistorical