FDA.reportPublic FDA data

CARVEDILOL

Product NDC
61919-533
11-digit product format
619190533
Labeler code
61919
Product ID
61919-533_872365ca-0c2b-550a-e053-2a91aa0ab25a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078384
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-533-302025-01-31C16284748780-11030e365-0033-111a-e063-dadaa90a10e2CARVEDILOL
61919-533-902025-01-31C16284748780-11030e365-0033-111a-e063-dadaa90a10e2CARVEDILOL
61919-533-302024-01-30C16284748780-11030e365-0033-111a-e063-dadaa90a10e2CARVEDILOL
61919-533-902024-01-30C16284748780-11030e365-0033-111a-e063-dadaa90a10e2CARVEDILOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-533-30CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED303
61919-533-90CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-533-90EA - Each61919-5337ff2a4f8-5177-4cc1-a63b-fd4657c8677612014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [DIRECT RX]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARVEDILOL TABLET, FILM COATED [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [DIRECT RX]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCARVEDILOL TABLET, FILM COATED [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-533CARVEDILOL TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 2 package rows20190423_d3992a3f-8347-476d-993e-16958c74efb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSNd3992a3f-8347-476d-993e-16958c74efb33
200033carvedilol 25 MG Oral TabletSCDd3992a3f-8347-476d-993e-16958c74efb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-533-306191905333030 TABLET, FILM COATED in 1 BOTTLE (61919-533-30) 2014-01-010000-00-00NoNoCurrent
61919-533-906191905339090 TABLET, FILM COATED in 1 BOTTLE (61919-533-90) 2014-01-010000-00-00NoNoCurrent