National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2013-05-02
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 04:08:44
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0456-3428-63 | EA - Each | 0456-3428 | f435fe01-8cbb-48fc-ba5f-2617ba3dc22f | 1 | 2013-05-02 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0456-3428 | 0456-3428-63 |
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 |
|---|---|---|---|---|---|---|---|
| N022525-001 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-002 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-003 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | |
| N022525-004 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | |
| N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-002 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-003 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | ||
| N022525-004 | 8039009 | 2029-03-24 | U-539 | ||
| N022525-004 | 8039009*PED | 2029-09-24 | 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 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022525-002 | NAMENDA XR | 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022525-003 | NAMENDA XR | 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022525-004 | NAMENDA XR | 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022525-002 | NAMENDA XR | 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022525-003 | NAMENDA XR | 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022525-004 | NAMENDA XR | 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-001 | NAMENDA XR | 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-002 | NAMENDA XR | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-003 | NAMENDA XR | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022525-004 | NAMENDA XR | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2010-06-21 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022525-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022525-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022525-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022525-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022525-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022525-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022525-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022525-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022525-004 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022525-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022525-003 | AB | 1 | 5aa47cf7b7d7… |
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 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-002 | 8039009 | 2029-03-24 | U-539 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-003 | 8039009 | 2029-03-24 | U-539 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-004 | 8039009 | 2029-03-24 | U-539 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | 8039009 | 2029-03-24 | U-539 | 2011-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022525-001 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-002 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-003 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | 8039009 | 2029-03-24 | U-539 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N022525-004 | 8039009*PED | 2029-09-24 | Pediatric extension | 6a471c1ec25d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.