FDA.reportPublic FDA data

Carvedilol

Product NDC
71610-132
11-digit product format
716100132
Labeler code
71610
Product ID
71610-132_64a15efb-fbe4-409a-93e4-dc27c54ac748
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078332
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
3.125 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], 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
Carvedilol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-132-53Carvedilol60 in 1 BOTTLETABLET, FILM COATED601
71610-132-60Carvedilol90 in 1 BOTTLETABLET, FILM COATED901
71610-132-80Carvedilol180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-132-53EA - Each71610-1324706895a-2d5b-40a3-b741-5f92c08b85b412018-11-06
71610-132-60EA - Each71610-132103a1d59-2e31-4d74-9be9-b4b49cf4273012018-11-06
71610-132-80EA - Each71610-1325965ead6-98dd-49ea-8f9f-ea7bb3aea72912018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-132CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20180925_d0089df4-37c8-41de-810c-14c9dc06f0c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNd0089df4-37c8-41de-810c-14c9dc06f0c31
686924carvedilol 3.125 MG Oral TabletSCDd0089df4-37c8-41de-810c-14c9dc06f0c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-132-537161001325360 TABLET, FILM COATED in 1 BOTTLE (71610-132-53) 2018-08-300000-00-00NoNoCurrent
71610-132-607161001326090 TABLET, FILM COATED in 1 BOTTLE (71610-132-60) 2018-08-300000-00-00NoNoCurrent
71610-132-8071610013280180 TABLET, FILM COATED in 1 BOTTLE (71610-132-80) 2018-08-300000-00-00NoNoCurrent