Carvedilol

Product NDC
10135-637
11-digit product format
101350637
Labeler code
10135
Product ID
10135-637_c7cf071b-67a3-42a3-891a-1024c4e658af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA078384
Marketing category
ANDA
Marketing start
2017-12-28
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
25 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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-637-01Carvedilol100 in 1 BOTTLETABLET1003
10135-637-05Carvedilol500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-637-01EA - Each10135-637dcf4d383-73cd-4c33-b218-84c86b85e1f512018-01-12
10135-637-05EA - Each10135-637ae9ca2f5-0014-4e1d-b8b6-f06a8ee21e8812018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-637CARVEDILOL TABLET [MARLEX PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20191112_b0d55eaa-7869-4d07-a92a-85ea0c598462.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNb0d55eaa-7869-4d07-a92a-85ea0c5984623
200033carvedilol 25 MG Oral TabletPSNb0d55eaa-7869-4d07-a92a-85ea0c5984623
686924carvedilol 3.125 MG Oral TabletPSNb0d55eaa-7869-4d07-a92a-85ea0c5984623
200031carvedilol 6.25 MG Oral TabletPSNb0d55eaa-7869-4d07-a92a-85ea0c5984623
200032carvedilol 12.5 MG Oral TabletSCDb0d55eaa-7869-4d07-a92a-85ea0c5984623
200033carvedilol 25 MG Oral TabletSCDb0d55eaa-7869-4d07-a92a-85ea0c5984623
686924carvedilol 3.125 MG Oral TabletSCDb0d55eaa-7869-4d07-a92a-85ea0c5984623
200031carvedilol 6.25 MG Oral TabletSCDb0d55eaa-7869-4d07-a92a-85ea0c5984623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-637-0110135063701100 in 1 BOTTLEHistorical
10135-637-0510135063705500 in 1 BOTTLEHistorical