FDA.reportPublic FDA data

Carvedilol

Product NDC
33261-975
11-digit product format
332610975
Labeler code
33261
Product ID
33261-975_725bef53-880f-4402-8b86-b732911c80bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078332
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
No
Listing certified through
2019-12-31
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
33261-975-302020-01-31C16284748780-19d75b9d0-fa3c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995
33261-975-602020-01-31C16284748780-19d75b9d0-fa3c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995
33261-975-902020-01-31C16284748780-19d75b9d0-fa3c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use carvedilol safely and effectively. See full prescribing information for carvedilol tablets, USP. Carvedilol Tablets, USP Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-975-30Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
33261-975-60Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
33261-975-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-975-30EA - Each33261-9758f4d1200-e92a-492d-8c8f-b3618a17f21112015-10-02
33261-975-60EA - Each33261-9758fe4278c-47d8-4f20-bd11-d725c2a3cf0312015-10-02
33261-975-90EA - Each33261-9756df535fb-1f59-4329-a9e8-68089aaeee7f12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-975CARVEDILOL TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_62408fc0-65d5-42f6-91a3-2c13f7697b39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
686924carvedilol 3.125 MG Oral TabletPSN62408fc0-65d5-42f6-91a3-2c13f7697b391
200032carvedilol 12.5 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391
686924carvedilol 3.125 MG Oral TabletSCD62408fc0-65d5-42f6-91a3-2c13f7697b391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-975-303326109753030 in 1 BOTTLE, PLASTICHistorical
33261-975-603326109756060 in 1 BOTTLE, PLASTICHistorical
33261-975-903326109759090 in 1 BOTTLEHistorical