FDA.reportPublic FDA data

Carvedilol

Product NDC
55111-254
11-digit product format
551110254
Labeler code
55111
Product ID
55111-254_31305b0b-ee75-85e9-081c-73d15c0a7b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076649
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
12.5 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
CARVEDILOL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 686924

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
55111-254-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED1008
55111-254-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED5008
55111-254-10Carvedilol1000 in 1 BOTTLETABLET, FILM COATED10008
55111-254-30Carvedilol30 in 1 BOTTLETABLET, FILM COATED308
55111-254-78Carvedilol10 in 1 CARTONTABLET, FILM COATED108
55111-254-79Carvedilol10 in 1 BLISTER PACKTABLET, FILM COATED108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-254-01EA - Each55111-2549ccda9da-eeb4-4a8f-9bf6-e5424e61661412012-07-24
55111-254-05EA - Each55111-254bd38edc0-a6e7-403e-905c-c3e004d0cdda12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]11
CarvedilolACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
CarvedilolACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
crospovidoneINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
povidoneINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-254CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC, 6 package rows20190312_1e453c21-a8a8-dc54-5591-74c972d41727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN506005f3-d79d-4de1-8bd2-71ade18b8d4711
200032carvedilol 12.5 MG Oral TabletSCD506005f3-d79d-4de1-8bd2-71ade18b8d4711
200032carvedilol 12.5 MG Oral TabletPSN1e453c21-a8a8-dc54-5591-74c972d417278
200033carvedilol 25 MG Oral TabletPSN1e453c21-a8a8-dc54-5591-74c972d417278
686924carvedilol 3.125 MG Oral TabletPSN1e453c21-a8a8-dc54-5591-74c972d417278
200031carvedilol 6.25 MG Oral TabletPSN1e453c21-a8a8-dc54-5591-74c972d417278
200032carvedilol 12.5 MG Oral TabletSCD1e453c21-a8a8-dc54-5591-74c972d417278
200033carvedilol 25 MG Oral TabletSCD1e453c21-a8a8-dc54-5591-74c972d417278
686924carvedilol 3.125 MG Oral TabletSCD1e453c21-a8a8-dc54-5591-74c972d417278
200031carvedilol 6.25 MG Oral TabletSCD1e453c21-a8a8-dc54-5591-74c972d417278

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-254-0155111025401100 TABLET, FILM COATED in 1 BOTTLE (55111-254-01) 2007-09-050000-00-00NoNoCurrent
55111-254-0555111025405500 TABLET, FILM COATED in 1 BOTTLE (55111-254-05) 2007-09-050000-00-00NoNoCurrent
55111-254-10551110254101000 TABLET, FILM COATED in 1 BOTTLE (55111-254-10) 2007-09-050000-00-00NoNoCurrent
55111-254-305511102543030 TABLET, FILM COATED in 1 BOTTLE (55111-254-30) 2007-09-050000-00-00NoNoCurrent
55111-254-785511102547810 BLISTER PACK in 1 CARTON (55111-254-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-254-79) 10 blister pack2007-09-050000-00-00NoNoCurrent
55111-254-795511102547910 in 1 BLISTER PACKHistorical