Home NDC 55111-254 Carvedilol
Product NDC 55111-254
11-digit product format 551110254
Labeler code 55111
Product ID 55111-254_31305b0b-ee75-85e9-081c-73d15c0a7b83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA076649
Marketing category ANDA
Marketing start 2007-09-05
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
Listing certified through 2026-12-31
Current FDA listing Yes 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 A076649-001 CARVEDILOL CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 A076649-002 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 A076649-003 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 A076649-004 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 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076649-004 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076649-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076649-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076649-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076649-004 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
Listing expiration 2026-12-31 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 55111-254-01 Carvedilol 100 in 1 BOTTLE TABLET, FILM COATED 100 8 55111-254-05 Carvedilol 500 in 1 BOTTLE TABLET, FILM COATED 500 8 55111-254-10 Carvedilol 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 55111-254-30 Carvedilol 30 in 1 BOTTLE TABLET, FILM COATED 30 8 55111-254-78 Carvedilol 10 in 1 CARTON TABLET, FILM COATED 10 8 55111-254-79 Carvedilol 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC] 11 Carvedilol ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 Carvedilol ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 crospovidone INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 povidone INACTIVE INGREDIENT FZ989GH94E CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-254 CARVEDILOL TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 8 Current NDC, Legacy NDC, 6 package rows 20190312_1e453c21-a8a8-dc54-5591-74c972d41727.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-254-01 55111025401 100 TABLET, FILM COATED in 1 BOTTLE (55111-254-01) 2007-09-05 0000-00-00 No No Current 55111-254-05 55111025405 500 TABLET, FILM COATED in 1 BOTTLE (55111-254-05) 2007-09-05 0000-00-00 No No Current 55111-254-10 55111025410 1000 TABLET, FILM COATED in 1 BOTTLE (55111-254-10) 2007-09-05 0000-00-00 No No Current 55111-254-30 55111025430 30 TABLET, FILM COATED in 1 BOTTLE (55111-254-30) 2007-09-05 0000-00-00 No No Current 55111-254-78 55111025478 10 BLISTER PACK in 1 CARTON (55111-254-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-254-79) 10 blister pack 2007-09-05 0000-00-00 No No Current 55111-254-79 55111025479 10 in 1 BLISTER PACK Historical