Bisoprolol Fumarate

Product NDC
71335-2244
11-digit product format
713352244
Labeler code
71335
Product ID
71335-2244_b77f45b2-ce63-417b-abdb-e6f807c1ec6c
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
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

openFDA Listing Details

Product ID
71335-2244_b77f45b2-ce63-417b-abdb-e6f807c1ec6c
SPL ID
b77f45b2-ce63-417b-abdb-e6f807c1ec6c
Product type
HUMAN PRESCRIPTION DRUG
Finished product
Yes
Brand name base
Bisoprolol Fumarate
Generic name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Marketing start
2009-09-21
Marketing category
ANDA
Application number
ANDA078635
Pharmacologic classes
Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration
2026-12-31

openFDA Active Ingredients

IngredientStrength
BISOPROLOL FUMARATE10 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiUR59KN573L
Rxcui854901
Spl Set Id4f11e64c-732e-419a-bc29-9cd2ff86d0b9
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
71335-2244-130 TABLET in 1 BOTTLE, PLASTIC (71335-2244-1)2023-09-22No
71335-2244-2120 TABLET in 1 BOTTLE, PLASTIC (71335-2244-2)2023-09-22No
71335-2244-3180 TABLET in 1 BOTTLE, PLASTIC (71335-2244-3)2023-09-22No
71335-2244-490 TABLET in 1 BOTTLE, PLASTIC (71335-2244-4)2023-09-22No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
UR59KN573LBISOPROLOL FUMARATE104344-23-2BISOPROLOL FUMARATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2244-17133522440130 TABLET in 1 BOTTLE, PLASTIC (71335-2244-1) 30 tablet2023-09-22NoNoHistorical
71335-2244-271335224402120 TABLET in 1 BOTTLE, PLASTIC (71335-2244-2) 120 tablet2023-09-22NoNoHistorical
71335-2244-371335224403180 TABLET in 1 BOTTLE, PLASTIC (71335-2244-3) 180 tablet2023-09-22NoNoHistorical
71335-2244-47133522440490 TABLET in 1 BOTTLE, PLASTIC (71335-2244-4) 90 tablet2023-09-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bisoprolol Fumarate Tablets USPBryant Ranch Prepack2023-09-22HUMAN PRESCRIPTION DRUG LABEL100