FDA.reportPublic FDA data

Carvedilol

Product NDC
70518-1826
11-digit product format
705181826
Labeler code
70518
Product ID
70518-1826_49769da8-48e6-66df-e063-6294a90a2dbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2019-01-26
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1826-02023-03-06C16284748780-1f386c64a-098b-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
70518-1826-12023-03-06C16284748780-1f386c64a-098b-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
70518-1826-22023-03-06C16284748780-1f386c64a-098b-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
70518-1826-02023-01-30C16284748780-1f386c64a-098b-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
70518-1826-12023-01-30C16284748780-1f386c64a-098b-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
70518-1826-22023-01-30C16284748780-1f386c64a-098b-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
70518-1826-0Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-1826-1Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18013
70518-1826-2Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1826-0EA - Each70518-182651e78826-e50a-4477-9512-3ac1873553c212026-01-08
70518-1826-1EA - Each70518-182688572f57-10a2-4bc0-9124-074a1c77f7e012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1826CARVEDILOL TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250302_0e98593a-8424-48c8-acc0-671f4b566aee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN0e98593a-8424-48c8-acc0-671f4b566aee13
200033carvedilol 25 MG Oral TabletSCD0e98593a-8424-48c8-acc0-671f4b566aee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1826-07051818260030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1826-0) 2019-01-260000-00-00NoNoCurrent
70518-1826-170518182601180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1826-1) 2019-03-130000-00-00NoNoCurrent
70518-1826-27051818260290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1826-2) 2019-04-260000-00-00NoNoCurrent