Home NDC 57664-242 Carvedilol
Product NDC 57664-242
11-digit product format 576640242
Labeler code 57664
Product ID 57664-242_231b19c0-5ee3-33c1-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA077346
Marketing category ANDA
Marketing start 2007-09-05
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 2019-12-31
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 2 · 96 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077346-001 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 A077346-002 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 A077346-003 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL 2007-09-05 A077346-004 CARVEDILOL CARVEDILOL 3.125MG 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 · 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 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077346-001 CARVEDILOL 6.25MG TABLET / ORAL 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077346-002 CARVEDILOL 12.5MG TABLET / ORAL 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077346-003 CARVEDILOL 25MG TABLET / ORAL 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077346-004 CARVEDILOL 3.125MG TABLET / ORAL 2007-09-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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 [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 POVIDONE INACTIVE INGREDIENT FZ989GH94E CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 SUCROSE INACTIVE INGREDIENT C151H8M554 CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13