FDA.reportPublic FDA data

Albendazole

Product NDC
43598-452
11-digit product format
435980452
Labeler code
43598
Product ID
43598-452_370b6498-30f2-48a4-f32a-9ee671cf294e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA211034
Marketing category
ANDA
Marketing start
2021-01-26
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
43598-452-02Albendazole2 in 1 BOTTLETABLET, FILM COATED25
43598-452-17Albendazole8 in 1 BLISTER PACKTABLET, FILM COATED85
43598-452-17Albendazole1 in 1 CARTONTABLET, FILM COATED15
43598-452-63Albendazole28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-452-02EA - Each43598-45234fbe011-172a-4760-8de5-54496362a71512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-452ALBENDAZOLE TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]5Current NDC, Legacy NDC, 4 package rows20210129_9ac95554-94c9-1f38-8f49-ec11979e4ba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN9ac95554-94c9-1f38-8f49-ec11979e4ba45
199672albendazole 200 MG Oral TabletSCD9ac95554-94c9-1f38-8f49-ec11979e4ba45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-452-02435980452022 TABLET, FILM COATED in 1 BOTTLE (43598-452-02) 2021-01-260000-00-00NoNoCurrent
43598-452-17435980452171 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-01-260000-00-00NoNoCurrent
43598-452-634359804526328 TABLET, FILM COATED in 1 BOTTLE (43598-452-63) 2021-01-260000-00-00NoNoCurrent