Bisoprolol Fumarate

Product NDC
16714-529
11-digit product format
167140529
Labeler code
16714
Product ID
16714-529_169e7bf6-19d7-4dc5-bfc7-35c5a8e4cf18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
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
16714-529-01Bisoprolol Fumarate30 in 1 BOTTLETABLET, FILM COATED302
16714-529-02Bisoprolol Fumarate100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-529-01EA - Each16714-5290c0dff67-b8c0-46ac-aeb0-61b5074450b312022-10-06
16714-529-02EA - Each16714-529e583740a-1ce1-4676-92a4-208eb6fce9e012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-529BISOPROLOL FUMARATE TABLET, FILM COATED [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 2 package rows20240606_4bf3278c-116f-4db7-9af0-08faaf7691a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN4bf3278c-116f-4db7-9af0-08faaf7691a42
854905bisoprolol fumarate 5 MG Oral TabletPSN4bf3278c-116f-4db7-9af0-08faaf7691a42
854901bisoprolol fumarate 10 MG Oral TabletSCD4bf3278c-116f-4db7-9af0-08faaf7691a42
854905bisoprolol fumarate 5 MG Oral TabletSCD4bf3278c-116f-4db7-9af0-08faaf7691a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-529-011671405290130 TABLET, FILM COATED in 1 BOTTLE (16714-529-01) 2006-12-270000-00-00NoNoCurrent
16714-529-0216714052902100 TABLET, FILM COATED in 1 BOTTLE (16714-529-02) 2006-12-270000-00-00NoNoCurrent