FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
69238-2580
11-digit product format
692382580
Labeler code
69238
Product ID
69238-2580_7bae176f-58e3-4d75-9609-80079f391e1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA204717
Marketing category
ANDA
Marketing start
2023-08-01
Substance
CARVEDILOL PHOSPHATE
Active strength
80 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 Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEQT531S367
Rxcui860510, 860516, 860522, 860532

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
69238-2580-1Carvedilol Phosphate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1004
69238-2580-2Carvedilol Phosphate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10004
69238-2580-3Carvedilol Phosphate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
69238-2580-9Carvedilol Phosphate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2580CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, 4 package rows20250521_dbec7c4b-3db7-4c9d-b5da-e72050ee5743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNdbec7c4b-3db7-4c9d-b5da-e72050ee57434
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDdbec7c4b-3db7-4c9d-b5da-e72050ee57434
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDdbec7c4b-3db7-4c9d-b5da-e72050ee57434
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDdbec7c4b-3db7-4c9d-b5da-e72050ee57434
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYdbec7c4b-3db7-4c9d-b5da-e72050ee57434
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYdbec7c4b-3db7-4c9d-b5da-e72050ee57434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-2580-169238258001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-1) 2023-08-01NoNoHistorical
69238-2580-2692382580021000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-2) 2023-08-01NoNoHistorical
69238-2580-36923825800330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-3) 2023-08-01NoNoHistorical
69238-2580-96923825800990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-9) 2023-08-01NoNoHistorical