BISOPROLOL FUMARATE

Product NDC
62332-604
11-digit product format
623320604
Labeler code
62332
Product ID
62332-604_918dc4a5-ef02-4ab0-8664-7c02b23e37b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BISOPROLOL FUMARATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA204891
Marketing category
ANDA
Marketing start
2019-09-11
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
62332-604-30BISOPROLOL FUMARATE30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
62332-604-31BISOPROLOL FUMARATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
62332-604-71BISOPROLOL FUMARATE500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-604-30EA - Each62332-604241806c2-6142-477c-b6cd-179db996b2cf12021-12-08
62332-604-31EA - Each62332-6046fbb9e5b-1cff-4cdb-94b9-53ca6838a06b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-604BISOPROLOL FUMARATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 3 package rows20211009_9b2eb4ea-001e-436c-93ba-20a7f5bc5f04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854901bisoprolol fumarate 10 MG Oral TabletPSN9b2eb4ea-001e-436c-93ba-20a7f5bc5f042
854905bisoprolol fumarate 5 MG Oral TabletPSN9b2eb4ea-001e-436c-93ba-20a7f5bc5f042
854901bisoprolol fumarate 10 MG Oral TabletSCD9b2eb4ea-001e-436c-93ba-20a7f5bc5f042
854905bisoprolol fumarate 5 MG Oral TabletSCD9b2eb4ea-001e-436c-93ba-20a7f5bc5f042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-604-306233206043030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-604-30) 2019-09-110000-00-00NoNoCurrent
62332-604-3162332060431100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-604-31) 2021-03-250000-00-00NoNoCurrent
62332-604-7162332060471500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62332-604-71) 2019-09-110000-00-00NoNoCurrent