FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
71335-9707
11-digit product format
713359707
Labeler code
71335
Product ID
71335-9707_0acb6c82-0308-4d04-b717-16acff5517ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090132
Marketing category
ANDA
Marketing start
2017-11-08
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
Rxcui860516

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
71335-9707-1Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE30102
71335-9707-2Carvedilol Phosphate90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9707-1EA - Each71335-970775df8ba5-a557-4b0c-99a4-dd61403b818f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9707CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240410_ce9623f8-6cea-45e0-a15c-2dd78690f2a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNce9623f8-6cea-45e0-a15c-2dd78690f2a7102
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDce9623f8-6cea-45e0-a15c-2dd78690f2a7102
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYce9623f8-6cea-45e0-a15c-2dd78690f2a7102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9707-17133597070130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-9707-1) 2023-05-05NoNoHistorical
71335-9707-27133597070290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-9707-2) 2023-05-05NoNoHistorical