FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
16714-228
11-digit product format
167140228
Labeler code
16714
Product ID
16714-228_484a4fc4-b967-349e-e063-6394a90aa41f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA090132
Marketing category
ANDA
Marketing start
2021-07-22
Substance
CARVEDILOL PHOSPHATE
Active strength
20 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 PHOSPHATE20 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
16714-228-01Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-228-01EA - Each16714-228d9d67500-1065-4635-881c-54e9f779717812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-228CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [NORTHSTAR RXLLC]2Current NDC, Legacy NDC, 1 package rows20240308_63065e30-4a50-42b0-9622-a393923c1e98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSN63065e30-4a50-42b0-9622-a393923c1e983
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSN63065e30-4a50-42b0-9622-a393923c1e983
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSN63065e30-4a50-42b0-9622-a393923c1e983
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSN63065e30-4a50-42b0-9622-a393923c1e983
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCD63065e30-4a50-42b0-9622-a393923c1e983
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCD63065e30-4a50-42b0-9622-a393923c1e983
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCD63065e30-4a50-42b0-9622-a393923c1e983
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCD63065e30-4a50-42b0-9622-a393923c1e983
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSY63065e30-4a50-42b0-9622-a393923c1e983
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSY63065e30-4a50-42b0-9622-a393923c1e983
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSY63065e30-4a50-42b0-9622-a393923c1e983
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSY63065e30-4a50-42b0-9622-a393923c1e983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-228-011671402280130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16714-228-01) 2021-07-220000-00-00NoNoCurrent