Home NDC 68151-5048 COREG
Product NDC 68151-5048
11-digit product format 681515048
Labeler code 68151
Product ID 68151-5048_b799abd8-149f-488a-98dd-73c367a2a3d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carvedilol phosphate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Carilion Materials Management
Application NDA022012
Marketing category NDA
Marketing start 2007-02-09
Marketing end 0000-00-00
Substance CARVEDILOL PHOSPHATE
Active strength 10 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 E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68151-5048-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68151-5048-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68151-5048-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68151-5048-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68151-5048-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68151-5048-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68151-5048-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68151-5048-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68151-5048-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68151-5048-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68151-5048-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68151-5048-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68151-5048-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68151-5048-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68151-5048-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68151-5048-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68151-5048-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68151-5048-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68151-5048-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 68151-5048-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 68151-5048-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68151-5048-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 N022012-001 COREG CR CARVEDILOL PHOSPHATE 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-002 COREG CR CARVEDILOL PHOSPHATE 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-003 COREG CR CARVEDILOL PHOSPHATE 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 N022012-004 COREG CR CARVEDILOL PHOSPHATE 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022012-001 8101209 2025-09-11 Drug product 2012-02-21 N022012-001 8101209*PED 2026-03-11 Pediatric extension N022012-002 8101209 2025-09-11 Drug product N022012-002 8101209*PED 2026-03-11 Pediatric extension N022012-003 8101209 2025-09-11 Drug product N022012-003 8101209*PED 2026-03-11 Pediatric extension N022012-004 8101209 2025-09-11 Drug product N022012-004 8101209*PED 2026-03-11 Pediatric extension
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 · 180 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 2026-11-14 07:37:17 2026-10 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 2006-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022012-001 COREG CR 10MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022012-002 COREG CR 20MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022012-003 COREG CR 40MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022012-004 COREG CR 80MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2006-10-20 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Observed Orange Book patent history# Patent history page 1 of 17 · 648 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68151-5048-1 COREGCR 1 in 1 PACKAGE CAPSULE, EXTENDED RELEASE 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARVEDILOL PHOSPHATE ACTIVE INGREDIENT EQT531S367 COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 CARVEDILOL ACTIVE MOIETY 0K47UL67F2 COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 HYDROGENATED CASTOR OIL INACTIVE INGREDIENT ZF94AP8MEY COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68151-5048 COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT] 3 Legacy NDC, 1 package rows 20160806_7b2638f5-8975-4259-be52-0da5c263bcc0.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coreg CR CARVEDILOL PHOSPHATE Waylis Therapeutics LLC d3625d78-6eb6-41fe-8f6f-664965c104c4 2025-04-25 Warnings, Adverse reactions Exact identifier application applno (NDA): 022012 application number: NDA022012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68151-5048-1 68151504801 1 in 1 PACKAGE Historical