FDA.reportPublic FDA data

Carvedilol

Product NDC
70518-1377
11-digit product format
705181377
Labeler code
70518
Product ID
70518-1377_5038ef0e-2361-6450-e063-6394a90ac2a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2018-08-15
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
70518-1377-0Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED3019
70518-1377-1Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18019
70518-1377-2Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
70518-1377-3Carvedilol100 in 1 BOXTABLET, FILM COATED10019
70518-1377-4Carvedilol1 in 1 POUCHTABLET, FILM COATED119
70518-1377-5Carvedilol100 in 1 BOXTABLET, FILM COATED10019
70518-1377-6Carvedilol1 in 1 POUCHTABLET, FILM COATED119
70518-1377-7Carvedilol50 in 1 BOXTABLET, FILM COATED5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1377-0EA - Each70518-1377e6c12ac8-1d55-4d7c-8978-7e7e5f20a7c012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1377CARVEDILOL TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 8 package rows20250524_32098c09-7580-4975-a3e1-31b619c04c69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSN32098c09-7580-4975-a3e1-31b619c04c6919
686924carvedilol 3.125 MG Oral TabletSCD32098c09-7580-4975-a3e1-31b619c04c6919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1377-07051813770030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1377-0) 2018-08-150000-00-00NoNoCurrent
70518-1377-170518137701180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1377-1) 2019-07-090000-00-00NoNoCurrent
70518-1377-27051813770290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1377-2) 2020-01-300000-00-00NoNoCurrent
70518-1377-370518137703100 POUCH in 1 BOX (70518-1377-3) > 1 TABLET, FILM COATED in 1 POUCH (70518-1377-4) 100 pouch2021-08-030000-00-00NoNoCurrent
70518-1377-4705181377041 in 1 POUCHHistorical
70518-1377-570518137705100 POUCH in 1 BOX (70518-1377-5) / 1 TABLET, FILM COATED in 1 POUCH (70518-1377-6) 100 pouch2025-05-14NoNoCurrent
70518-1377-6705181377061 in 1 POUCHHistorical
70518-1377-77051813770750 POUCH in 1 BOX (70518-1377-7) / 1 TABLET, FILM COATED in 1 POUCH (70518-1377-6) 50 pouch2026-04-24NoNoCurrent