Bisoprolol Fumarate

Product NDC
21695-667
11-digit product format
216950667
Labeler code
21695
Product ID
21695-667_d82243b9-3e56-4a2b-8750-cb95ec106885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA078635
Marketing category
ANDA
Marketing start
2009-09-21
Marketing end
0000-00-00
Substance
BISOPROLOL FUMARATE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-667-302019-09-24C16284748780-1934fe258-47f4-48b1-e053-8cdaa90a720aBisoprolol Fumarate Tablets USP
21695-667-902019-09-24C16284748780-1934fe258-47f4-48b1-e053-8cdaa90a720aBisoprolol Fumarate Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-667-30Bisoprolol Fumarate30 in 1 BOTTLE, PLASTICTABLET301
21695-667-90Bisoprolol Fumarate90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-667-30EA - Each21695-667a2b5c2be-7fe5-4285-96c7-7d4b925afc5d12012-07-24
21695-667-90EA - Each21695-6676dd4ba5e-9549-432c-99fd-fe8337c0bdf312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISOPROLOL FUMARATEACTIVE INGREDIENTUR59KN573LBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
BISOPROLOLACTIVE MOIETYY41JS2NL6UBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-667BISOPROLOL FUMARATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110413_d82243b9-3e56-4a2b-8750-cb95ec106885.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSNd82243b9-3e56-4a2b-8750-cb95ec1068851
854905bisoprolol fumarate 5 MG Oral TabletPSNd82243b9-3e56-4a2b-8750-cb95ec1068851
854901bisoprolol fumarate 10 MG Oral TabletSCDd82243b9-3e56-4a2b-8750-cb95ec1068851
854905bisoprolol fumarate 5 MG Oral TabletSCDd82243b9-3e56-4a2b-8750-cb95ec1068851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-667-302169506673030 in 1 BOTTLE, PLASTICHistorical
21695-667-902169506679090 in 1 BOTTLE, PLASTICHistorical