FDA.reportPublic FDA data

Carvedilol

Product NDC
70518-0356
11-digit product format
705180356
Labeler code
70518
Product ID
70518-0356_47f499bc-5ca2-7097-e063-6294a90a61b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2017-03-23
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
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0356-0Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED3020
70518-0356-1Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18020
70518-0356-2Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
70518-0356-3Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0356-0EA - Each70518-0356cba80dfa-a934-4bd9-a98c-a2bab9e15d1512025-12-16
70518-0356-1EA - Each70518-035630c21b42-a18c-432d-99bd-15f0e4d584b812025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0356CARVEDILOL TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 4 package rows20250426_39cf31cc-8f3d-4919-a93a-f997ad6850dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN39cf31cc-8f3d-4919-a93a-f997ad6850dc20
200032carvedilol 12.5 MG Oral TabletSCD39cf31cc-8f3d-4919-a93a-f997ad6850dc20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0356-07051803560030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0356-0) 2017-03-230000-00-00NoNoCurrent
70518-0356-170518035601180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0356-1) 2017-10-160000-00-00NoNoCurrent
70518-0356-27051803560260 in 1 BOTTLE, PLASTICHistorical
70518-0356-37051803560390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0356-3) 2019-04-300000-00-00NoNoCurrent