National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:32:38
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0007-3372-13 | EA - Each | 0007-3372 | b87f8b88-5752-455d-85a9-cbf28867df93 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0007-3372 | 0007-3372-13 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022012-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022012-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022012-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022012-004 | AB | 1 | 84e616aacf4f… |
| 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… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022012-001 | 8101209 | 2025-09-11 | Drug product | 2012-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022012-001 | 8101209*PED | 2026-03-11 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-002 | 8101209 | 2025-09-11 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-002 | 8101209*PED | 2026-03-11 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-003 | 8101209 | 2025-09-11 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-003 | 8101209*PED | 2026-03-11 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-004 | 8101209 | 2025-09-11 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022012-004 | 8101209*PED | 2026-03-11 | Pediatric extension | 84e616aacf4f… | ||
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.