Home NDC 55154-7278 Carvedilol
Product NDC 55154-7278
11-digit product format 551547278
Labeler code 55154
Product ID 55154-7278_79a44689-e948-4c79-af9a-94c5ebdcbbef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA078227
Marketing category ANDA
Marketing start 2012-11-14
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 2024-12-31
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 · 4 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 55154-7278-0 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 55154-7278-0 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078227-001 CARVEDILOL CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 A078227-002 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 A078227-003 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 A078227-004 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05
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 · 172 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 2026-09-14 22:38:34 2026-08 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 3
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-7278-0 55154727800 10 BLISTER PACK in 1 BAG (55154-7278-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2012-11-14 0000-00-00 No No Current