Home NDC 72888-501-02 Carvedilol
Product NDC 72888-501
Requested package NDC 72888-501-02
11-digit product format 728880501
Labeler code 72888
Product ID 72888-501_4b7daf77-d3f7-0b55-e063-6394a90a84fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advagen Pharma Limited
Application ANDA078786
Marketing category ANDA
Marketing start 2025-09-17
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 2027-12-31
Current FDA listing Yes 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 A078786-001 CARVEDILOL CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 A078786-002 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 A078786-003 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 A078786-004 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22
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 · 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 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL AB 2009-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL AB 2009-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL AB 2009-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078786-004 CARVEDILOL 25MG TABLET / ORAL AB 2009-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078786-001 CARVEDILOL 3.125MG TABLET / ORAL 2009-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078786-002 CARVEDILOL 6.25MG TABLET / ORAL 2009-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078786-003 CARVEDILOL 12.5MG TABLET / ORAL 2009-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078786-004 CARVEDILOL 25MG TABLET / ORAL 2009-12-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Carvedilol
Listing expiration 2027-12-31 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 72888-501-01 Carvedilol 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2 72888-501-02 Carvedilol 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 2 72888-501-03 Carvedilol 1000 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1000 2
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 Sample Exclude flag Status 72888-501-02 72888050102 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72888-501-02) 2025-09-17 No No Current