Albendazole

Product NDC
42799-110
11-digit product format
427990110
Labeler code
42799
Product ID
42799-110_462d7a10-6aa8-b8fa-e063-6394a90a2cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albendazole
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA211117
Marketing category
ANDA
Marketing start
2019-05-17
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
42799-110-02Albendazole2 in 1 BOTTLETABLET242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-110-02EA - Each42799-1109d94ed21-6240-4133-b568-3814239eafa812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42799-110ALBENDAZOLE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]41Current NDC, Legacy NDC, 1 package rows20200722_6c48fd89-cb40-477c-8a78-15cbe0df6faa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN6c48fd89-cb40-477c-8a78-15cbe0df6faa42
199672albendazole 200 MG Oral TabletSCD6c48fd89-cb40-477c-8a78-15cbe0df6faa42
199672albendazole 200 MG Oral TabletPSN8de337eb-92e1-15b5-e053-2a95a90ac4f14
199672albendazole 200 MG Oral TabletSCD8de337eb-92e1-15b5-e053-2a95a90ac4f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-110-02427990110022 TABLET in 1 BOTTLE (42799-110-02) 2 tablet2019-05-170000-00-00NoNoCurrent