COREG
- Product NDC
- 0007-3370
- 11-digit product format
- 000073370
- Labeler code
- 0007
- Product ID
- 0007-3370_a25fd7cf-8270-4fc1-8e72-7b10ce17d088
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carvedilol phosphate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- GlaxoSmithKline LLC
- Application
- NDA022012
- Marketing category
- NDA
- Marketing start
- 2007-02-09
- Marketing end
- 2023-04-30
- 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
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0007-3370 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0007-3370 | 0007-3370-13 | D | Discontinued by firm | 2026-08-17 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0007-3370-13 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0007-3370-13 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0007-3370-13 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0007-3370-13 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0007-3370-13 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0007-3370-13 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0007-3370-13 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0007-3370-13 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0007-3370-13 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0007-3370-13 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0007-3370-13 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0007-3370-13 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N022012-001 | AB |
| N022012-002 | AB |
| N022012-003 | AB |
| N022012-004 | AB |
Orange Book patents#
| 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.
| 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 | 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… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022012-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022012-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022012-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022012-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-004 | AB | 1 | 6a471c1ec25d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022012-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022012-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022012-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022012-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022012-004 | AB | 1 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-002 | 8101209 | 2025-09-11 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-003 | 8101209 | 2025-09-11 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-004 | 8101209 | 2025-09-11 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-002 | 8101209 | 2025-09-11 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-003 | 8101209 | 2025-09-11 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-004 | 8101209 | 2025-09-11 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-002 | 8101209 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-003 | 8101209 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-004 | 8101209 | 2025-09-11 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-002 | 8101209 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-003 | 8101209 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-004 | 8101209 | 2025-09-11 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-002 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-003 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-004 | 8101209 | 2025-09-11 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | fd3edfee7708… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e148a93c-bfff-2735-e6c0-0739297b4596 | Product name | 3 | 20180705 |
| 32d6365f-9f0e-0782-b719-48e651893fb7 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0007-3370-13 | EA - Each | 0007-3370 | 09371de6-a83f-4c8b-b162-0108a3591409 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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.
| 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 | 022012 NDA022012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860510 | carvedilol phosphate 10 MG 24HR Extended Release Oral Capsule | PSN | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860512 | COREG CR 10 MG 24HR Extended Release Oral Capsule | PSN | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860512 | 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg] | SBD | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860510 | 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule | SCD | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860512 | 24 HR Coreg 10 MG Extended Release Oral Capsule | SY | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860510 | carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule | SY | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860512 | Coreg CR 10 MG 24 HR Extended Release Oral Capsule | SY | 7b2638f5-8975-4259-be52-0da5c263bcc0 | 3 |
| 860510 | carvedilol phosphate 10 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860516 | carvedilol phosphate 20 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860522 | carvedilol phosphate 40 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860532 | carvedilol phosphate 80 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860512 | COREG CR 10 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860518 | COREG CR 20 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860524 | Coreg CR 40 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860534 | COREG CR 80 MG 24HR Extended Release Oral Capsule | PSN | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860512 | 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg] | SBD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860518 | 24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule [Coreg] | SBD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860524 | 24 HR carvedilol phosphate 40 MG Extended Release Oral Capsule [Coreg] | SBD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860534 | 24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg] | SBD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860510 | 24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule | SCD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860516 | 24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule | SCD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860522 | 24 HR carvedilol phosphate 40 MG Extended Release Oral Capsule | SCD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860532 | 24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule | SCD | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860512 | 24 HR Coreg 10 MG Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860518 | 24 HR Coreg 20 MG Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860524 | 24 HR Coreg 40 MG Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860534 | 24 HR Coreg 80 MG Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860510 | carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860516 | carvedilol phosphate 20 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860522 | carvedilol phosphate 40 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860532 | carvedilol phosphate 80 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860512 | Coreg CR 10 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860518 | Coreg CR 20 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860524 | Coreg CR 40 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
| 860534 | Coreg CR 80 MG 24 HR Extended Release Oral Capsule | SY | bbf4dd22-f1e3-4101-89fb-31f5df3bfbc4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0007-3370-13 | 00007337013 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3370-13) | 2007-02-09 | 2023-04-30 | No | No | Current |