Home NDC 0378-3631 Carvedilol
Product NDC 0378-3631
11-digit product format 003783631
Labeler code 0378
Product ID 0378-3631_c2e2be0a-f08c-4a26-a1e0-f82017ba6dc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA077316
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 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 5 CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
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 0378-3631-01 00378363101 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3631-01) 2007-09-05 0000-00-00 No No Current 0378-3631-05 00378363105 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3631-05) 2007-09-05 0000-00-00 No No Current