FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-4898
11-digit product format
500904898
Labeler code
50090
Product ID
50090-4898_b7432b96-4546-4a59-9ed1-9ba146d4b40a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078251
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4898-02023-02-06C16284748780-1f386c64a-01a5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995
50090-4898-02023-01-30C16284748780-1f386c64a-01a5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4898-0Carvedilol90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4898-0EA - Each50090-48982d46d0e0-c969-41ce-88fd-7cc0123718a312026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN3c8d54e6-835c-4fa7-b13b-b798916cfed36
200033carvedilol 25 MG Oral TabletSCD3c8d54e6-835c-4fa7-b13b-b798916cfed36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4898-05009048980090 TABLET, FILM COATED in 1 BOTTLE (50090-4898-0) 2020-02-140000-00-00NoNoCurrent