Albendazole

Product NDC
0591-2712
11-digit product format
005912712
Labeler code
0591
Product ID
0591-2712_071a50e4-8606-40a7-b09c-e7281ccac80b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA208094
Marketing category
ANDA
Marketing start
2019-06-13
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
0591-2712-02Albendazole2 in 1 BOTTLETABLET, FILM COATED212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2712-02EA - Each0591-2712e438278e-1cff-408c-ad10-2c3f33b671b512019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2712ALBENDAZOLE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12Current NDC, Legacy NDC, 1 package rows20220804_f5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSNf5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b12
199672albendazole 200 MG Oral TabletSCDf5c7b8cb-a81f-4b13-b3c4-f6edaf880d3b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2712-000059127120015016 TABLET, FILM COATED in 1 BOX (0591-2712-00)13-JUN-19Current
0591-2712-02005912712022 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02) 2019-06-130000-00-00NoNoCurrent
0591-2712-770059127127718024 TABLET, FILM COATED in 1 CONTAINER (0591-2712-77)22-AUG-24Current