FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-1069
11-digit product format
500901069
Labeler code
50090
Product ID
50090-1069_621aac65-5084-47e8-ae0a-e74db49a5736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078332
Marketing category
ANDA
Marketing start
2007-09-05
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
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
CARVEDILOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033

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
50090-1069-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED6028
50090-1069-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED18028
50090-1069-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED9028
50090-1069-4Carvedilol30 in 1 BOTTLETABLET, FILM COATED3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1069-0EA - Each50090-1069db7436a1-3a7e-40b2-872c-9f7b0c88e4b112021-08-05
50090-1069-1EA - Each50090-106940773752-74d6-4ead-8074-70a827889c0112021-08-05
50090-1069-3EA - Each50090-1069316f495a-89b8-408d-9e6d-f0e0b83be3f912022-12-07
50090-1069-4EA - Each50090-1069409e4752-c858-44b9-9574-6f75c93fd00212022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1069CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]26Current NDC, Legacy NDC, 4 package rows20250417_f5969d18-46c7-4f35-9668-2fd4f6bbeb17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200033carvedilol 25 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200031carvedilol 6.25 MG Oral TabletPSNf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200032carvedilol 12.5 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200033carvedilol 25 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728
200031carvedilol 6.25 MG Oral TabletSCDf5969d18-46c7-4f35-9668-2fd4f6bbeb1728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1069-05009010690060 TABLET, FILM COATED in 1 BOTTLE (50090-1069-0) 2014-11-280000-00-00NoNoCurrent
50090-1069-150090106901180 TABLET, FILM COATED in 1 BOTTLE (50090-1069-1) 2014-11-280000-00-00NoNoCurrent
50090-1069-35009010690390 TABLET, FILM COATED in 1 BOTTLE (50090-1069-3) 2014-11-280000-00-00NoNoCurrent
50090-1069-45009010690430 TABLET, FILM COATED in 1 BOTTLE (50090-1069-4) 2014-11-280000-00-00NoNoCurrent