FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
65862-086
11-digit product format
658620086
Labeler code
65862
Product ID
65862-086_bb3ee6c5-1c46-41c6-890b-d775a103111a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077910
Marketing category
ANDA
Marketing start
2006-12-27
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
65862-086-01Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED10010
65862-086-30Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-086-01EA - Each65862-08631f6ee83-188a-4ddc-a4b8-764dcf4c744612012-07-24
65862-086-30EA - Each65862-086347036e0-206a-44b6-b0dc-9e57d26d43ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-086BISOPROLOL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 2 package rows20240606_2564646d-183c-4759-8726-155a4c22aa2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN2564646d-183c-4759-8726-155a4c22aa2b10
854905bisoprolol fumarate 5 MG Oral TabletPSN2564646d-183c-4759-8726-155a4c22aa2b10
854901bisoprolol fumarate 10 MG Oral TabletSCD2564646d-183c-4759-8726-155a4c22aa2b10
854905bisoprolol fumarate 5 MG Oral TabletSCD2564646d-183c-4759-8726-155a4c22aa2b10
854905bisoprolol fumarate 5 MG Oral TabletPSNd540ef44-9016-9d66-e053-2a95a90a16a92
854905bisoprolol fumarate 5 MG Oral TabletSCDd540ef44-9016-9d66-e053-2a95a90a16a92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-086-0165862008601100 TABLET, FILM COATED in 1 BOTTLE (65862-086-01) 2006-12-270000-00-00NoNoCurrent
65862-086-306586200863030 TABLET, FILM COATED in 1 BOTTLE (65862-086-30) 2006-12-270000-00-00NoNoCurrent
65862-086-81658620086818000 TABLET, FILM COATED in 1 BAG (65862-086-81)27-DEC-06Current