Home NDC 0007-4142 COREG
Product NDC 0007-4142
11-digit product format 000074142
Labeler code 0007
Product ID 0007-4142_5d3c75e2-3d90-4263-b276-38330ad96a76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA020297
Marketing category NDA
Marketing start 1997-06-03
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0007-4142-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0007-4142-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0007-4142-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0007-4142-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0007-4142-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0007-4142-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0007-4142-20 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0007-4142-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0007-4142-20 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0007-4142-20 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0007-4142-20 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0007-4142-20 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020297-001 COREG CARVEDILOL 25MG TABLET / ORAL AB RLD 1995-09-14 N020297-002 COREG CARVEDILOL 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 N020297-003 COREG CARVEDILOL 6.25MG TABLET / ORAL AB RLD 1995-09-14 N020297-004 COREG CARVEDILOL 3.125MG TABLET / ORAL AB RLD 1997-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020297-001 COREG 25MG TABLET / ORAL AB RLD 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-002 COREG 12.5MG TABLET / ORAL AB RLD, RS 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-003 COREG 6.25MG TABLET / ORAL AB RLD 1995-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020297-004 COREG 3.125MG TABLET / ORAL AB RLD 1997-05-29 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 LACTOSE INACTIVE INGREDIENT J2B2A4N98G COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 POVIDONES INACTIVE INGREDIENT FZ989GH94E COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 SUCROSE INACTIVE INGREDIENT C151H8M554 COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COREG (CARVEDILOL) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] 19 CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COREG (CARVEDILOL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coreg CARVEDILOL Waylis Therapeutics LLC 07c619c6-4a0c-445e-94fa-664a54f68a39 2026-07-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 020297 application number: NDA020297
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0007-4142-20 00007414220 100 TABLET, FILM COATED in 1 BOTTLE (0007-4142-20) 1997-06-03 0000-00-00 No No Current