FDA.reportPublic FDA data

Bisoprolol Fumarate

Product NDC
0093-5271
11-digit product format
000935271
Labeler code
0093
Product ID
0093-5271_cb429bf9-326b-460f-9f9a-9e81deb97f2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075644
Marketing category
ANDA
Marketing start
2004-06-01
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5271-56EA - Each0093-527172f09e5c-535d-47a9-b384-7c2f3b5de40c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSNb9bbf9ed-4781-42a9-bc3e-deda9f05e8102
854905bisoprolol fumarate 5 MG Oral TabletPSNb9bbf9ed-4781-42a9-bc3e-deda9f05e8102
854901bisoprolol fumarate 10 MG Oral TabletSCDb9bbf9ed-4781-42a9-bc3e-deda9f05e8102
854905bisoprolol fumarate 5 MG Oral TabletSCDb9bbf9ed-4781-42a9-bc3e-deda9f05e8102