Carvedilol Phosphate

Product NDC
0115-1248
11-digit product format
001151248
Labeler code
0115
Product ID
0115-1248_ad7423a5-e5c2-4a50-a338-c25370dba2a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL PHOSPHATE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA204717
Marketing category
ANDA
Marketing start
2024-01-01
Substance
CARVEDILOL PHOSPHATE
Active strength
10 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 PHOSPHATE10 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
0115-1248-01Carvedilol Phosphate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10016
0115-1248-03Carvedilol Phosphate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100016
0115-1248-08Carvedilol Phosphate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3016
0115-1248-10Carvedilol Phosphate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1248-08EA - Each0115-12485fbc67e8-e042-4e74-8cd7-5d48e79fae0412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1248CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]16Current NDC, Legacy NDC, 4 package rows20250503_fa6b4014-e9d7-4074-95fc-4b48d91da83b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYfa6b4014-e9d7-4074-95fc-4b48d91da83b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1248-0100115124801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) 2024-01-010000-00-00NoNoCurrent
0115-1248-03001151248031000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) 2024-01-010000-00-00NoNoCurrent
0115-1248-080011512480830 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) 2024-01-010000-00-00NoNoCurrent
0115-1248-100011512481090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10) 2024-01-010000-00-00NoNoCurrent