FDA.reportPublic FDA data

Carvedilol

Product NDC
63187-941
11-digit product format
631870941
Labeler code
63187
Product ID
63187-941_f83cec53-93fb-4fa6-81e8-5e8801c99e62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
63187-941-30Carvedilol30 in 1 BOTTLETABLET, FILM COATED304
63187-941-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED604
63187-941-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-941-60EA - Each63187-941c3261cf6-fd36-4cce-a22f-2f6abd74467212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-941CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200229_55a19ff1-f8c1-4cf0-8711-9bfa32756de9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN55a19ff1-f8c1-4cf0-8711-9bfa32756de94
686924carvedilol 3.125 MG Oral TabletSCD55a19ff1-f8c1-4cf0-8711-9bfa32756de94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-941-306318709413030 TABLET, FILM COATED in 1 BOTTLE (63187-941-30) 2017-12-010000-00-00NoNoCurrent
63187-941-606318709416060 TABLET, FILM COATED in 1 BOTTLE (63187-941-60) 2017-12-010000-00-00NoNoCurrent
63187-941-906318709419090 TABLET, FILM COATED in 1 BOTTLE (63187-941-90) 2017-12-010000-00-00NoNoCurrent