Bisoprolol Fumarate

Product NDC
63629-5173
11-digit product format
636295173
Labeler code
63629
Product ID
63629-5173_e5b82db7-5871-48fa-8d1d-26be3d9698cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078635
Marketing category
ANDA
Marketing start
2009-09-21
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
63629-5173-1Bisoprolol Fumarate30 in 1 BOTTLETABLET301011
63629-5173-2Bisoprolol Fumarate100 in 1 BOTTLETABLET1001011
63629-5173-3Bisoprolol Fumarate90 in 1 BOTTLETABLET901011
63629-5173-4Bisoprolol Fumarate28 in 1 BOTTLETABLET281011
63629-5173-5Bisoprolol Fumarate120 in 1 BOTTLETABLET1201011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5173BISOPROLOL FUMARATE TABLET [BRYANT RANCH PREPACK]1011Current NDC, Legacy NDC, 5 package rows20231118_428ef54d-8828-4756-a087-a1b7b2d6b8d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSN428ef54d-8828-4756-a087-a1b7b2d6b8d61011
854905bisoprolol fumarate 5 MG Oral TabletSCD428ef54d-8828-4756-a087-a1b7b2d6b8d61011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5173-16362951730130 TABLET in 1 BOTTLE (63629-5173-1) 30 tablet2013-12-160000-00-00NoNoCurrent
63629-5173-263629517302100 TABLET in 1 BOTTLE (63629-5173-2) 100 tablet2013-12-160000-00-00NoNoCurrent
63629-5173-36362951730390 TABLET in 1 BOTTLE (63629-5173-3) 90 tablet2013-12-160000-00-00NoNoCurrent
63629-5173-46362951730428 TABLET in 1 BOTTLE (63629-5173-4) 28 tablet2013-12-160000-00-00NoNoCurrent
63629-5173-563629517305120 TABLET in 1 BOTTLE (63629-5173-5) 120 tablet2013-12-160000-00-00NoNoCurrent