Home NDC 0781-5223 Carvedilol
Product NDC 0781-5223
11-digit product format 007815223
Labeler code 0781
Product ID 0781-5223_56b48372-0a73-4242-a65c-2b65abdb70c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA078227
Marketing category ANDA
Marketing start 2007-09-05
Marketing end 2026-08-31
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
Current FDA listing Yes 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 · 24 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 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 · 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078227-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078227-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078227-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078227-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Carvedilol 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200031 Internal RxNorm lookup 200032 Internal RxNorm lookup 200033 Internal RxNorm lookup 686924 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 0781-5223-01 Carvedilol 100 in 1 BOTTLE TABLET, FILM COATED 100 11 0781-5223-29 Carvedilol 60 in 1 BLISTER PACK TABLET, FILM COATED 60 11 0781-5223-60 Carvedilol 60 in 1 BOTTLE TABLET, FILM COATED 60 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 11 CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 POVIDONE K12 INACTIVE INGREDIENT 333AG72FWJ CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 6 CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5223 CARVEDILOL TABLET, FILM COATED [SANDOZ INC] 11 Current NDC, Legacy NDC, 3 package rows 20250425_da8b8c20-0130-4aa9-924d-4a4f28c3f767.zip
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 · 2 matching rows.
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 0781-5223-01 00781522301 100 TABLET, FILM COATED in 1 BOTTLE (0781-5223-01) 2007-09-05 2026-08-31 No No Current 0781-5223-29 00781522329 60 in 1 BLISTER PACK Historical 0781-5223-60 00781522360 60 in 1 BOTTLE Historical