BISOPROLOL FUMARATE

Product NDC
72789-392
11-digit product format
727890392
Labeler code
72789
Product ID
72789-392_31f66fad-b441-4f0e-e063-6394a90a3518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISOPROLOL FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA217617
Marketing category
ANDA
Marketing start
2024-03-10
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
Rxcui854905

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
72789-392-82BISOPROLOL FUMARATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-392BISOPROLOL FUMARATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]5Current NDC, 1 package rows20250406_c8fa858c-7e42-4134-9fc6-604a11a66fe2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSNc8fa858c-7e42-4134-9fc6-604a11a66fe25
854905bisoprolol fumarate 5 MG Oral TabletSCDc8fa858c-7e42-4134-9fc6-604a11a66fe25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-392-8272789039282500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-392-82) 2024-04-17NoNoCurrent