FDA.reportPublic FDA data

CARVEDILOL

Product NDC
50090-7849
11-digit product format
500907849
Labeler code
50090
Product ID
50090-7849_fd7346c4-4f59-48ad-a3fd-d64636e10952
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
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
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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200033

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
50090-7849-0CARVEDILOL60 in 1 BOTTLETABLET, FILM COATED601
50090-7849-1CARVEDILOL180 in 1 BOTTLETABLET, FILM COATED1801
50090-7849-3CARVEDILOL90 in 1 BOTTLETABLET, FILM COATED901
50090-7849-4CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7849-0EA - Each50090-78492da69184-1067-4f12-9a31-deaf2508ccf512026-02-05
50090-7849-1EA - Each50090-7849a29c18bf-f1d3-46bf-860e-817657ab1f2c12026-02-05
50090-7849-3EA - Each50090-784983546cf9-b2f4-4be4-89e7-84ab2a75ab1a12026-02-05
50090-7849-4EA - Each50090-7849678b8423-9603-4571-b9cd-0809c8b743b412026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN947baca7-f9c8-4821-b47b-53c45288613e1
200033carvedilol 25 MG Oral TabletSCD947baca7-f9c8-4821-b47b-53c45288613e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7849-05009078490060 TABLET, FILM COATED in 1 BOTTLE (50090-7849-0) 2026-01-06NoNoHistorical
50090-7849-150090784901180 TABLET, FILM COATED in 1 BOTTLE (50090-7849-1) 2026-01-06NoNoHistorical
50090-7849-35009078490390 TABLET, FILM COATED in 1 BOTTLE (50090-7849-3) 2026-01-06NoNoHistorical
50090-7849-45009078490430 TABLET, FILM COATED in 1 BOTTLE (50090-7849-4) 2026-01-06NoNoHistorical