Home NDC 80725-141 Coreg
Product NDC 80725-141
11-digit product format 807250141
Labeler code 80725
Product ID 80725-141_f2798247-00df-4ec2-a6f8-1902f10b5558
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Waylis Therapeutics LLC
Application NDA020297
Marketing category NDA
Marketing start 2023-03-15
Substance CARVEDILOL
Active strength 12.5 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 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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Coreg
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARVEDILOL 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0K47UL67F2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200031 Internal RxNorm lookup 200032 Internal RxNorm lookup 200033 Internal RxNorm lookup 212388 Internal RxNorm lookup 212389 Internal RxNorm lookup 212390 Internal RxNorm lookup 686924 Internal RxNorm lookup 686926 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80725-141-20 Coreg 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80725-141 COREG (CARVEDILOL) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC] 2 Current NDC, 1 package rows 20250126_07c619c6-4a0c-445e-94fa-664a54f68a39.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80725-141-20 80725014120 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-141-20) 2023-04-15 No No Current