FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-1067
11-digit product format
500901067
Labeler code
50090
Product ID
50090-1067_941273bc-d549-40dc-82d3-905563f8ac0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077614
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
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
Rxcui200032

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1067-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED604
50090-1067-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1804
50090-1067-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED904
50090-1067-4Carvedilol30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1067-0EA - Each50090-1067151feaee-bd49-48e8-9762-a6ece34bd20712023-10-16
50090-1067-1EA - Each50090-1067718ee9f2-02f3-464a-925c-9ddcbc1fe16c12023-10-16
50090-1067-3EA - Each50090-106766e5e94b-a774-49df-92ff-5eb41550a27a12023-10-16
50090-1067-4EA - Each50090-1067f4034082-f525-4553-9aeb-48b7f6a9d03f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1067CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]2Current NDC, 4 package rows20230828_157f64c6-2c21-4056-b643-79047ca237a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN157f64c6-2c21-4056-b643-79047ca237a94
200032carvedilol 12.5 MG Oral TabletSCD157f64c6-2c21-4056-b643-79047ca237a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1067-05009010670060 TABLET, FILM COATED in 1 BOTTLE (50090-1067-0) 2014-11-28NoNoHistorical
50090-1067-150090106701180 TABLET, FILM COATED in 1 BOTTLE (50090-1067-1) 2014-11-28NoNoHistorical
50090-1067-35009010670390 TABLET, FILM COATED in 1 BOTTLE (50090-1067-3) 2014-11-28NoNoHistorical
50090-1067-45009010670430 TABLET, FILM COATED in 1 BOTTLE (50090-1067-4) 2014-11-28NoNoHistorical