Carvedilol

Product NDC
70518-4389
11-digit product format
705184389
Labeler code
70518
Product ID
70518-4389_40320a33-73b7-c689-e063-6394a90aa708
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077614
Marketing category
ANDA
Marketing start
2025-07-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

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
70518-4389-0Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED303
70518-4389-1Carvedilol30 in 1 BLISTER PACKTABLET, FILM COATED303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNd7d6bfff-fbb6-4a1f-aa13-babbb9a1e8783
200032carvedilol 12.5 MG Oral TabletSCDd7d6bfff-fbb6-4a1f-aa13-babbb9a1e8783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4389-07051843890030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-0) 2025-07-08NoNoHistorical
70518-4389-17051843890130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-1) 2025-08-19NoNoHistorical