FDA.reportPublic FDA data

Carvedilol

Product NDC
43063-129
11-digit product format
430630129
Labeler code
43063
Product ID
43063-129_41378192-7e1a-7f74-e063-6294a90abd88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078332
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
Rxcui200033

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
43063-129-30Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3031
43063-129-60Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6031
43063-129-93Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-129-30EA - Each43063-1290214537e-0e8f-4974-a715-37851cf44a5b12014-05-02
43063-129-60EA - Each43063-129e9d561d1-8d34-4156-8e00-1d2bb2a3088412013-09-04
43063-129-93EA - Each43063-129ebd3ea45-e487-419a-9772-fb20bd22759812013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL (CARVEDILOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-129CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 3 package rows20240809_205da5d0-05d9-440d-bb5a-b30b826900ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN205da5d0-05d9-440d-bb5a-b30b826900ab31
200033carvedilol 25 MG Oral TabletSCD205da5d0-05d9-440d-bb5a-b30b826900ab31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-129-304306301293030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-129-30) 2014-02-190000-00-00NoNoCurrent
43063-129-604306301296060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-129-60) 2014-02-190000-00-00NoNoCurrent
43063-129-9343063012993180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-129-93) 2014-02-190000-00-00NoNoCurrent