Bisoprolol fumarate

Product NDC
69339-237
11-digit product format
693390237
Labeler code
69339
Product ID
69339-237_e907bfcb-5e64-45b8-ae9d-822b3d360104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma USA LLC
Application
ANDA075831
Marketing category
ANDA
Marketing start
2024-11-25
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bisoprolol fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE10 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
69339-237-01Bisoprolol fumarate100 in 1 BOTTLE, PLASTICTABLET1001
69339-237-03Bisoprolol fumarate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-237BISOPROLOL FUMARATE TABLET [NATCO PHARMA USA LLC]1Current NDC, 2 package rows20250125_e907bfcb-5e64-45b8-ae9d-822b3d360104.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSNe907bfcb-5e64-45b8-ae9d-822b3d3601041
854905bisoprolol fumarate 5 MG Oral TabletPSNe907bfcb-5e64-45b8-ae9d-822b3d3601041
854901bisoprolol fumarate 10 MG Oral TabletSCDe907bfcb-5e64-45b8-ae9d-822b3d3601041
854905bisoprolol fumarate 5 MG Oral TabletSCDe907bfcb-5e64-45b8-ae9d-822b3d3601041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69339-237-0169339023701100 TABLET in 1 BOTTLE, PLASTIC (69339-237-01) 100 tablet2024-11-25NoNoCurrent
69339-237-036933902370330 TABLET in 1 BOTTLE, PLASTIC (69339-237-03) 30 tablet2024-11-25NoNoCurrent