BISOPROLOL FUMARATE

Product NDC
72789-395
11-digit product format
727890395
Labeler code
72789
Product ID
72789-395_31f67825-d007-651f-e063-6394a90abab8
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
10 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 FUMARATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854901

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
72789-395-82BISOPROLOL FUMARATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-395BISOPROLOL FUMARATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]4Current NDC, 1 package rows20250406_6566dcbe-3e25-4828-9c10-3d041000bc77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN6566dcbe-3e25-4828-9c10-3d041000bc774
854901bisoprolol fumarate 10 MG Oral TabletSCD6566dcbe-3e25-4828-9c10-3d041000bc774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-395-8272789039582500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-395-82) 2024-03-10NoNoCurrent