FDA.reportPublic FDA data

COREG

Product NDC
0007-3373
11-digit product format
000073373
Labeler code
0007
Product ID
0007-3373_a25fd7cf-8270-4fc1-8e72-7b10ce17d088
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carvedilol phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA022012
Marketing category
NDA
Marketing start
2007-02-20
Marketing end
0000-00-00
Substance
CARVEDILOL PHOSPHATE
Active strength
80 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
2022-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0007-3373-132023-02-12C16284748780-1f386c649-b0ed-0266-e053-dadaa90a7c1a06400a4c-42b4-440a-92b4-1f47f98ac7ba
0007-3373-612023-02-12C16284748780-1f386c649-b0ed-0266-e053-dadaa90a7c1a06400a4c-42b4-440a-92b4-1f47f98ac7ba
0007-3373-132023-01-30C16284748780-1f386c649-b0ed-0266-e053-dadaa90a7c1a06400a4c-42b4-440a-92b4-1f47f98ac7ba
0007-3373-612023-01-30C16284748780-1f386c649-b0ed-0266-e053-dadaa90a7c1a06400a4c-42b4-440a-92b4-1f47f98ac7ba

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0007-3373-13EA - Each0007-3373e5588b66-d786-4417-b75b-13d95c74e1ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOL PHOSPHATEACTIVE INGREDIENTEQT531S367COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARVEDILOLACTIVE MOIETY0K47UL67F2COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCOREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CARVEDILOL PHOSPHATEACTIVE INGREDIENTEQT531S367COREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CARVEDILOLACTIVE MOIETY0K47UL67F2COREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCOREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCOREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECOREGCR CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSN4f997a0b-a4c9-4be8-9add-8d90c1c465e53
860534COREG CR 80 MG 24HR Extended Release Oral CapsulePSN4f997a0b-a4c9-4be8-9add-8d90c1c465e53
86053424 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]SBD4f997a0b-a4c9-4be8-9add-8d90c1c465e53
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCD4f997a0b-a4c9-4be8-9add-8d90c1c465e53
86053424 HR Coreg 80 MG Extended Release Oral CapsuleSY4f997a0b-a4c9-4be8-9add-8d90c1c465e53
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSY4f997a0b-a4c9-4be8-9add-8d90c1c465e53
860534Coreg CR 80 MG 24 HR Extended Release Oral CapsuleSY4f997a0b-a4c9-4be8-9add-8d90c1c465e53
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860512COREG CR 10 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860518COREG CR 20 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860524Coreg CR 40 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860534COREG CR 80 MG 24HR Extended Release Oral CapsulePSNbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051224 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg]SBDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051824 HR carvedilol phosphate 20 MG Extended Release Oral Capsule [Coreg]SBDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86052424 HR carvedilol phosphate 40 MG Extended Release Oral Capsule [Coreg]SBDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86053424 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]SBDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051224 HR Coreg 10 MG Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86051824 HR Coreg 20 MG Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86052424 HR Coreg 40 MG Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
86053424 HR Coreg 80 MG Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860512Coreg CR 10 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860518Coreg CR 20 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860524Coreg CR 40 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41
860534Coreg CR 80 MG 24 HR Extended Release Oral CapsuleSYbbf4dd22-f1e3-4101-89fb-31f5df3bfbc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0007-3373-130000733731330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3373-13) 2007-02-200000-00-00NoNoCurrent
0007-3373-61000073373617 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3373-61) 2007-02-200000-00-00NoNoCurrent