Home NDC 55154-5677 Carvedilol
Product NDC 55154-5677
11-digit product format 551545677
Labeler code 55154
Product ID 55154-5677_047065cc-d470-4b94-b65f-4ce62eb49f12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA077316
Marketing category ANDA
Marketing start 2011-02-18
Marketing end 0000-00-00
Substance CARVEDILOL
Active strength 3 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 2023-12-31
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 · 22 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 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 55154-5677-0 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077316-001 CARVEDILOL CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 A077316-002 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 A077316-003 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 A077316-004 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL 2007-09-05
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 · 168 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 2026-08-18 06:07:40 2026-07 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077316-004 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077316-004 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077316-004 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077316-004 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077316-001 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077316-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077316-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077316-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 137 observed states.
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] 15 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH] 15
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-5677-0 55154567700 10 BLISTER PACK in 1 BAG (55154-5677-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2011-02-18 0000-00-00 No No Current