Albendazole

Product NDC
0115-1701
11-digit product format
001151701
Labeler code
0115
Product ID
0115-1701_2da2a777-2835-429d-b73a-31b8e0bde571
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
NDA020666
Marketing category
NDA
Marketing start
1996-06-11
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
0115-1701-49Albendazole2 in 1 BOTTLETABLET, FILM COATED29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1701-49EA - Each0115-1701b9071a80-0fba-4b12-a9ca-8536032c4a5d12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1701ALBENDAZOLE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]9Current NDC, Legacy NDC, 1 package rows20240102_06b5eefc-0b95-4862-b9b6-770063f2adf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN06b5eefc-0b95-4862-b9b6-770063f2adf09
199672albendazole 200 MG Oral TabletSCD06b5eefc-0b95-4862-b9b6-770063f2adf09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1701-49001151701492 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49) 1996-06-110000-00-00NoNoCurrent