FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-1062
11-digit product format
500901062
Labeler code
50090
Product ID
50090-1062_ae7a30de-d871-4967-a26d-db3b329a7fa8
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
3.125 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
CARVEDILOL3.125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui686924

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
50090-1062-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED609
50090-1062-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1809
50090-1062-2Carvedilol30 in 1 BOTTLETABLET, FILM COATED309
50090-1062-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1062-0EA - Each50090-106266c16492-743d-4a38-84df-60abf180117e12024-02-14
50090-1062-1EA - Each50090-10620f20d2a2-d17f-4ee7-b04c-1d9793dba09112024-02-14
50090-1062-2EA - Each50090-10628ad5dce7-8eed-4142-9d07-f9c95b301e2a12024-02-14
50090-1062-3EA - Each50090-1062e9b03abe-b2ff-4dad-90e7-86b5587a9ac412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1062CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, 4 package rows20240929_3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN3eb4fd8e-1027-4d24-8f2f-12e9dcfe62319
686924carvedilol 3.125 MG Oral TabletSCD3eb4fd8e-1027-4d24-8f2f-12e9dcfe62319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1062-05009010620060 TABLET, FILM COATED in 1 BOTTLE (50090-1062-0) 2014-11-28NoNoHistorical
50090-1062-150090106201180 TABLET, FILM COATED in 1 BOTTLE (50090-1062-1) 2014-11-28NoNoHistorical
50090-1062-25009010620230 TABLET, FILM COATED in 1 BOTTLE (50090-1062-2) 2014-11-28NoNoHistorical
50090-1062-35009010620390 TABLET, FILM COATED in 1 BOTTLE (50090-1062-3) 2023-11-28NoNoHistorical