Albendazole

Product NDC
46708-681
11-digit product format
467080681
Labeler code
46708
Product ID
46708-681_3b4945c7-56e9-47ed-a7ac-5078a1a50b85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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
46708-681-02Albendazole2 in 1 BOTTLETABLET, FILM COATED21
46708-681-28Albendazole28 in 1 BOTTLETABLET, FILM COATED281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-681ALBENDAZOLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240919_3b4945c7-56e9-47ed-a7ac-5078a1a50b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN3b4945c7-56e9-47ed-a7ac-5078a1a50b851
199672albendazole 200 MG Oral TabletSCD3b4945c7-56e9-47ed-a7ac-5078a1a50b851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-681-02467080681022 TABLET, FILM COATED in 1 BOTTLE (46708-681-02) 2024-09-11NoNoCurrent
46708-681-284670806812828 TABLET, FILM COATED in 1 BOTTLE (46708-681-28) 2024-09-11NoNoCurrent