FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
42291-481
11-digit product format
422910481
Labeler code
42291
Product ID
42291-481_4a7c3ea5-24e9-8ace-e063-6294a90a879d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA204717
Marketing category
ANDA
Marketing start
2024-06-27
Substance
CARVEDILOL PHOSPHATE
Active strength
40 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 Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE40 mg/1

Harmonized Identifiers#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-481-30Carvedilol Phosphate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-481-30EA - Each42291-4813ea3481e-8378-4d72-8f8b-a4de4a5f819e12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-481CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [AVKARE]1Current NDC, 1 package rows20240629_1be1b5d2-eb2c-1d02-e063-6294a90adbba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSN1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSN1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSN1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSN1be1b5d2-eb2c-1d02-e063-6294a90adbba3
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCD1be1b5d2-eb2c-1d02-e063-6294a90adbba3
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCD1be1b5d2-eb2c-1d02-e063-6294a90adbba3
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCD1be1b5d2-eb2c-1d02-e063-6294a90adbba3
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCD1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSY1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSY1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSY1be1b5d2-eb2c-1d02-e063-6294a90adbba3
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSY1be1b5d2-eb2c-1d02-e063-6294a90adbba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-481-304229104813030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-481-30) 2024-06-27NoNoCurrent