Home NDC 68084-854 Carvedilol
Product NDC 68084-854
11-digit product format 680840854
Labeler code 68084
Product ID 68084-854_2e949f24-e7de-0a5d-e063-6394a90a97d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carvedilol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA077614
Marketing category ANDA
Marketing start 2015-05-04
Substance CARVEDILOL
Active strength 6.25 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 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 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 · 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 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…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077614-001 CARVEDILOL 6.25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077614-002 CARVEDILOL 12.5MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077614-003 CARVEDILOL 25MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077614-004 CARVEDILOL 3.125MG TABLET / ORAL AB 2007-09-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARVEDILOL 6.25 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 200031 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 68084-854-01 Carvedilol 100 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 100 10 68084-854-11 Carvedilol 1 in 1 BLISTER PACK TABLET, FILM COATED 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL ACTIVE INGREDIENT 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68084-854 CARVEDILOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 10 Current NDC, Legacy NDC, 2 package rows 20250223_a97a2467-7525-467c-8969-38246903690c.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 Units Marketing start Marketing end Sample Exclude flag Status 68084-854-01 68084085401 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-854-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-854-11) 100 blister pack 2015-05-04 0000-00-00 No No Current 68084-854-11 68084085411 1 in 1 BLISTER PACK Historical