FDA.reportPublic FDA data

Carvedilol

Product NDC
52959-204
11-digit product format
529590204
Labeler code
52959
Product ID
52959-204_68fe3dfd-c27f-4558-b1b1-6aff37213809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
13 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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-204-302019-11-13C16284748780-197449f38-c296-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets, USP. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-204-30Hypertenevide-12.530 in 1 BOTTLETABLET3012.5 mg7
52959-204-30Carvedilol30 in 1 BOTTLETABLET302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARGININEACTIVE INGREDIENT94ZLA3W45FHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CARVEDILOLACTIVE INGREDIENT0K47UL67F2HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
ARGININEACTIVE MOIETY94ZLA3W45FHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CARVEDILOLACTIVE MOIETY0K47UL67F2HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
GELATININACTIVE INGREDIENT2G86QN327LHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-204HYPERTENEVIDE-12.5 (CARVEDILOL, ARGININE) KIT [PHYSICIAN THERAPEUTICS LLC]7Legacy NDC20110812_4400de87-e9c4-4a0e-9275-1715a12ab46d.zip
52959-204CARVEDILOL TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111209_354d1689-53f9-42d3-8308-08b6d9a04404.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN4400de87-e9c4-4a0e-9275-1715a12ab46d7
200032carvedilol 12.5 MG Oral TabletSCD4400de87-e9c4-4a0e-9275-1715a12ab46d7
200032carvedilol 12.5 MG Oral TabletPSN354d1689-53f9-42d3-8308-08b6d9a044042
200032carvedilol 12.5 MG Oral TabletSCD354d1689-53f9-42d3-8308-08b6d9a044042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-204-305295902043030 in 1 BOTTLEHistorical