FDA.reportPublic FDA data

Carvedilol

Product NDC
71610-063
11-digit product format
716100063
Labeler code
71610
Product ID
71610-063_dc72ac05-4435-4c84-ab22-2514e65b9fde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078384
Marketing category
ANDA
Marketing start
2018-02-01
Substance
CARVEDILOL
Active strength
6.25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0K47UL67F2
Rxcui200031, 200032, 200033, 686924

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
71610-063-30Carvedilol30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71610-063-53Carvedilol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71610-063-60Carvedilol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901
71610-063-80Carvedilol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-063-30EA - Each71610-0635213ef30-fb8c-4f89-a194-ebb63db9963712018-08-13
71610-063-53EA - Each71610-0634b9d3659-6e38-442c-865f-d1c8825703be12018-08-13
71610-063-60EA - Each71610-063994d6a16-8707-41c5-9e3d-ed08f8e97e9c12018-08-13
71610-063-80EA - Each71610-063a5abc9dc-a879-40ae-83ff-873a3fd92df112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-063CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20180620_e3f463b5-2743-4a4a-a90a-bf1ee10a5458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNe3f463b5-2743-4a4a-a90a-bf1ee10a54581
200033carvedilol 25 MG Oral TabletPSNe3f463b5-2743-4a4a-a90a-bf1ee10a54581
686924carvedilol 3.125 MG Oral TabletPSNe3f463b5-2743-4a4a-a90a-bf1ee10a54581
200031carvedilol 6.25 MG Oral TabletPSNe3f463b5-2743-4a4a-a90a-bf1ee10a54581
200032carvedilol 12.5 MG Oral TabletSCDe3f463b5-2743-4a4a-a90a-bf1ee10a54581
200033carvedilol 25 MG Oral TabletSCDe3f463b5-2743-4a4a-a90a-bf1ee10a54581
686924carvedilol 3.125 MG Oral TabletSCDe3f463b5-2743-4a4a-a90a-bf1ee10a54581
200031carvedilol 6.25 MG Oral TabletSCDe3f463b5-2743-4a4a-a90a-bf1ee10a54581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-063-307161000633030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-30) 2018-05-150000-00-00NoNoCurrent
71610-063-537161000635360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-53) 2018-05-150000-00-00NoNoCurrent
71610-063-607161000636090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-60) 2018-05-150000-00-00NoNoCurrent
71610-063-8071610006380180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-80) 2018-05-080000-00-00NoNoCurrent