Home NDC 50090-6949 Carvedilol
Product NDC 50090-6949
11-digit product format 500906949
Labeler code 50090
Product ID 50090-6949_c5a7e15f-73f4-4d21-a5d7-c3847d9734b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA077614
Marketing category ANDA
Marketing start 2007-09-05
Substance CARVEDILOL
Active strength 3.125 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 44 .
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 A077614-001 CARVEDILOL CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 A077614-002 CARVEDILOL CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 A077614-003 CARVEDILOL CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 A077614-004 CARVEDILOL CARVEDILOL 3.125MG 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 · 176 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 2026-10-15 13:18:30 2026-09 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
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 3.125 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 50090-6949-0 Carvedilol 90 in 1 BOTTLE TABLET, FILM COATED 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6949 CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 3 Current NDC, 1 package rows 20231227_add1ee3d-fca4-4301-b871-7dda6eda7bb7.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 3 of 3 · 45 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carvedilol CARVEDILOL Bryant Ranch Prepack da830b08-1cdd-4d36-a068-c376fd7763c4 2024-08-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077614 application number: ANDA077614 Carvedilol CARVEDILOL Proficient Rx LP 0bfea06d-7abe-407a-80a4-d15d373569f7 2024-07-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077614 application number: ANDA077614 Carvedilol CARVEDILOL NuCare Pharmaceuticals,Inc. e31271aa-259b-caa6-e053-2995a90a0fcd 2024-06-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077614 application number: ANDA077614 Carvedilol CARVEDILOL NuCare Pharmaceuticals,Inc. 8ccf07f5-78fb-76da-e053-2a95a90a0090 2024-06-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077614 application number: ANDA077614 Carvedilol CARVEDILOL NuCare Pharmaceuticals, Inc. 49afdf89-0bed-71da-e054-00144ff88e88 2024-01-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 077614 application number: ANDA077614
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50090-6949-0 50090694900 90 TABLET, FILM COATED in 1 BOTTLE (50090-6949-0) 2023-12-18 No No Current