FDA.reportPublic FDA data

Carvedilol

Product NDC
70518-0426
11-digit product format
705180426
Labeler code
70518
Product ID
70518-0426_47f62cc3-3c94-dd33-e063-6294a90a1793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2017-04-17
Substance
CARVEDILOL
Active strength
6.25 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
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031

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
70518-0426-0Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED3020
70518-0426-1Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18020
70518-0426-2Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6020
70518-0426-3Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3020
70518-0426-4Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0426-1EA - Each70518-0426c6a9c19f-7d73-4edf-bc38-0c30d7ad101a12026-01-08
70518-0426-4EA - Each70518-04268893993d-af90-42fd-9784-9616ef7bd8fc12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0426CARVEDILOL TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 5 package rows20250427_683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb20
200031carvedilol 6.25 MG Oral TabletSCD683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0426-07051804260030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0426-0) 2017-04-170000-00-00NoNoCurrent
70518-0426-170518042601180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0426-1) 2017-04-240000-00-00NoNoCurrent
70518-0426-27051804260260 in 1 BOTTLE, PLASTICHistorical
70518-0426-37051804260330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0426-3) 2018-11-060000-00-00NoNoCurrent
70518-0426-47051804260490 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0426-4) 2019-01-070000-00-00NoNoCurrent