Carvedilol Phosphate
- Product NDC
- 63629-8794
- 11-digit product format
- 636298794
- Labeler code
- 63629
- Product ID
- 63629-8794_d4499f41-6e21-461f-87b7-5bdd3601e604
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- carvedilol phosphate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA022012
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-11-01
- Marketing end
- 0000-00-00
- Substance
- CARVEDILOL PHOSPHATE
- Active strength
- 80 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
- 2023-12-31
- 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 | 63629-8794 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 63629-8794 | 63629-8794-1 | D | Discontinued by firm | 2026-08-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-001 | COREG CR | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-002 | COREG CR | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-003 | COREG CR | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2006-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022012-004 | COREG CR | 80MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD | 2006-10-20 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022012-004 | AB | 1 | 1e350fbaab3a… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-002 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-003 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-004 | 8101209 | 2025-09-11 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | b8a1b40f171c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8794-1 | EA - Each | 63629-8794 | 6e376148-efd5-4f27-aaf9-f61fdb5ef668 | 1 | 2021-11-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8794 | CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 102 | Legacy NDC | 20240112_77084f11-0750-44cd-a208-f38b3f62a1a1.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.
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-8794-1 | 63629879401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-8794-1) | 2021-09-10 | 0000-00-00 | No | No | Current |