FDA.reportPublic FDA data

Carvedilol

Product NDC
72888-501
11-digit product format
728880501
Labeler code
72888
Product ID
72888-501_4b7daf77-d3f7-0b55-e063-6394a90a84fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA078786
Marketing category
ANDA
Marketing start
2025-09-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2027-12-31

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
72888-501-01Carvedilol100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
72888-501-02Carvedilol500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
72888-501-03Carvedilol1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-501-01EA - Each72888-5019aa57fac-b8a2-4d9d-a357-bcdfa8bfea6c12026-04-20
72888-501-02EA - Each72888-5013a640509-d6a8-4422-80d2-faaad3ee8ec412025-12-16
72888-501-03EA - Each72888-5015864b64f-ab4f-4075-a64c-d94b54411e0212026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN205291ba-86a7-43e1-be47-bc75df1921f92
200033carvedilol 25 MG Oral TabletPSN205291ba-86a7-43e1-be47-bc75df1921f92
686924carvedilol 3.125 MG Oral TabletPSN205291ba-86a7-43e1-be47-bc75df1921f92
200031carvedilol 6.25 MG Oral TabletPSN205291ba-86a7-43e1-be47-bc75df1921f92
200032carvedilol 12.5 MG Oral TabletSCD205291ba-86a7-43e1-be47-bc75df1921f92
200033carvedilol 25 MG Oral TabletSCD205291ba-86a7-43e1-be47-bc75df1921f92
686924carvedilol 3.125 MG Oral TabletSCD205291ba-86a7-43e1-be47-bc75df1921f92
200031carvedilol 6.25 MG Oral TabletSCD205291ba-86a7-43e1-be47-bc75df1921f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72888-501-0172888050101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-01) 2025-09-17NoNoCurrent
72888-501-0272888050102500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-02) 2025-09-17NoNoCurrent
72888-501-03728880501031000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-03) 2025-09-17NoNoCurrent