FDA.reportPublic FDA data

Carvedilol

Product NDC
71335-1623
11-digit product format
713351623
Labeler code
71335
Product ID
71335-1623_b6e60516-209f-4738-ade3-6a8c1baf8205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
25 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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200032, 200033

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1623-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED1004
71335-1623-2Carvedilol30 in 1 BOTTLETABLET, FILM COATED304
71335-1623-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED904
71335-1623-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED604
71335-1623-5Carvedilol120 in 1 BOTTLETABLET, FILM COATED1204
71335-1623-6Carvedilol180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1623CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 6 package rows20240502_196536eb-8b94-45da-a2f3-f554d6bf88e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200032carvedilol 12.5 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1623-171335162301100 TABLET, FILM COATED in 1 BOTTLE (71335-1623-1) 2007-09-050000-00-00NoNoCurrent
71335-1623-27133516230230 TABLET, FILM COATED in 1 BOTTLE (71335-1623-2) 2007-09-050000-00-00NoNoCurrent
71335-1623-37133516230390 TABLET, FILM COATED in 1 BOTTLE (71335-1623-3) 2007-09-050000-00-00NoNoCurrent
71335-1623-47133516230460 TABLET, FILM COATED in 1 BOTTLE (71335-1623-4) 2007-09-050000-00-00NoNoCurrent
71335-1623-571335162305120 TABLET, FILM COATED in 1 BOTTLE (71335-1623-5) 2007-09-050000-00-00NoNoCurrent
71335-1623-671335162306180 TABLET, FILM COATED in 1 BOTTLE (71335-1623-6) 2007-09-050000-00-00NoNoCurrent