FDA.reportPublic FDA data

BISOPROLOL FUMARATE

Product NDC
46708-603
11-digit product format
467080603
Labeler code
46708
Product ID
46708-603_ae10b8e1-557d-4437-8a1d-89d7844122c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISOPROLOL FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204891
Marketing category
ANDA
Marketing start
2019-09-11
Substance
BISOPROLOL FUMARATE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BISOPROLOL FUMARATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854901, 854905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-603-30BISOPROLOL FUMARATE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
46708-603-31BISOPROLOL FUMARATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
46708-603-71BISOPROLOL FUMARATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-603BISOPROLOL FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20230208_ae10b8e1-557d-4437-8a1d-89d7844122c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSNae10b8e1-557d-4437-8a1d-89d7844122c81
854905bisoprolol fumarate 5 MG Oral TabletPSNae10b8e1-557d-4437-8a1d-89d7844122c81
854901bisoprolol fumarate 10 MG Oral TabletSCDae10b8e1-557d-4437-8a1d-89d7844122c81
854905bisoprolol fumarate 5 MG Oral TabletSCDae10b8e1-557d-4437-8a1d-89d7844122c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-603-304670806033030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30) 2019-09-11NoNoCurrent
46708-603-3146708060331100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31) 2021-03-25NoNoCurrent
46708-603-7146708060371500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-71) 2019-09-11NoNoCurrent