Dyanavel XR
- Product NDC
- 24478-102
- 11-digit product format
- 244780102
- Labeler code
- 24478
- Product ID
- 24478-102_32c90701-fe4a-4d5a-b3bb-e9ccf0416ece
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amphetamine
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NextWave Pharmaceuticals, Inc
- Application
- NDA208147
- Marketing category
- NDA
- Marketing start
- 2015-10-01
- Substance
- AMPHETAMINE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208147-001 | DYANAVEL XR | AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | |
| N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | |
| N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | |
| N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | |
| N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | |
| N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | |
| N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 |
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 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N208147-001 | DYANAVEL XR | EQ 2.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N208147-001 | DYANAVEL XR | 2MG/ML;EQ 0.5MG BASE/ML | SUSPENSION, EXTENDED RELEASE / ORAL | RLD, RS | 2015-10-19 | cb3db0bc1861… |
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 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 8062667 | 2029-03-29 | Drug product | 2015-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208147-001 | 11590228 | 2036-09-07 | U-3538 | Drug product | 2023-03-08 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | 10086087 | 2027-03-15 | Drug product | 2018-10-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | 8597684 | 2027-03-15 | Drug product | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | 8747902 | 2027-03-15 | Drug product | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | 8883217 | 2027-03-15 | Drug product | 2015-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208147-001 | 9675703 | 2027-03-15 | Drug product | 2017-06-28 | 03ed91905a0d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dyanavel XR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPHETAMINE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CK833KGX7E | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1720586 | Internal RxNorm lookup |
| 1720592 | Internal RxNorm lookup |
| 2585460 | Internal RxNorm lookup |
| 2585461 | Internal RxNorm lookup |
| 2585462 | Internal RxNorm lookup |
| 2585465 | Internal RxNorm lookup |
| 2585468 | Internal RxNorm lookup |
| 2585471 | Internal RxNorm lookup |
| 2585473 | Internal RxNorm lookup |
| 2585476 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0f66b30d-6b15-4b2d-91a5-1531b9bb6d21 | Product name | 7 | 20250625 |
| 917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b | Product name | 2 | 20250616 |
| 8b92ab59-8b26-4c89-a2d6-8d5140526ec6 | Product name | 3 | 20231213 |
| 4496d022-9224-4ee0-943a-50fbe6cd7123 | Product name | 2 | 20220901 |
| 2a7aa275-a4ca-44eb-971f-47427a374085 | Product name | 9 | 20220615 |
| 93730fbf-8b45-4623-b27d-cf03825d04b3 | Product name | 5 | 20220314 |
| a90f088a-9578-47a2-8f6e-0a9d32aafec6 | Product name | 1 | 20181030 |
| f6c90bdc-1674-455a-aadd-1b1b59e5edeb | Product name | 2 | 20181030 |
| 57953747-955c-4dd8-9164-49d8ea877eae | Product name | 1 | 20171113 |
| fcc7ea58-a369-4e91-b092-5cde9ac2669f | Product name | 1 | 20160224 |
| f1ec5c2f-d01e-a277-5826-c7eba86ed99b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24478-102-01 | Dyanavel XR | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 | |
| 24478-102-01 | Dyanavel XR | 464 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 464 | 14 | |
| 24478-102-02 | Dyanavel XR | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | 14 | |
| 24478-102-02 | Dyanavel XR | 60 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 60 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24478-102-01 | ML - Milliliter | 24478-102 | 3299ae96-b3c8-421b-854e-89f189fea69e | 1 | 2022-10-06 |
| 24478-102-02 | ML - Milliliter | 24478-102 | 14a9b16c-511f-433f-a722-5cb165267901 | 1 | 2026-04-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 24478-102 | DYANAVEL XR (AMPHETAMINE) SUSPENSION, EXTENDED RELEASE DYANAVEL XR (AMPHETAMINE) TABLET, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231027_ae304b29-0b40-40ec-ad0d-76b742d4a9b9.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 |
|---|---|---|---|---|---|---|
| Dyanavel XR | AMPHETAMINE | NextWave Pharmaceuticals, Inc | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 2026-02-24 | Boxed warning, Warnings, Adverse reactions | 208147 NDA208147 24478-102 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2585460 | amphetamine 10 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585462 | amphetamine 15 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720586 | amphetamine 2.5 MG in 1 mL 24HR Extended Release Suspension | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585468 | amphetamine 20 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585473 | amphetamine 5 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585461 | Dyanavel XR 10 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585465 | Dyanavel XR 15 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720592 | Dyanavel XR 2.5 MG in 1 mL 24HR Extended Release Oral Suspension | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585471 | Dyanavel XR 20 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585476 | Dyanavel XR 5 MG 24HR Extended Release Oral Tablet | PSN | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585461 | 24 HR amphetamine 10 MG Extended Release Oral Tablet [Dyanavel] | SBD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585465 | 24 HR amphetamine 15 MG Extended Release Oral Tablet [Dyanavel] | SBD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720592 | 24 HR amphetamine 2.5 MG/ML Extended Release Suspension [Dyanavel] | SBD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585471 | 24 HR amphetamine 20 MG Extended Release Oral Tablet [Dyanavel] | SBD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585476 | 24 HR amphetamine 5 MG Extended Release Oral Tablet [Dyanavel] | SBD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585460 | 24 HR amphetamine 10 MG Extended Release Oral Tablet | SCD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585462 | 24 HR amphetamine 15 MG Extended Release Oral Tablet | SCD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720586 | 24 HR amphetamine 2.5 MG/ML Extended Release Suspension | SCD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585468 | 24 HR amphetamine 20 MG Extended Release Oral Tablet | SCD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585473 | 24 HR amphetamine 5 MG Extended Release Oral Tablet | SCD | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720592 | 24 HR Dyanavel 2.5 MG/ML Extended Release Suspension | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720586 | amphetamine 2.5 MG per 1 ML 24 HR Extended Release Suspension | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720586 | amphetamine 2.5 MG/ML 24 HR Extended Release Suspension | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585461 | Dyanavel 10 MG 24 HR Extended Release Oral Tablet | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585465 | Dyanavel 15 MG 24 HR Extended Release Oral Tablet | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585471 | Dyanavel 20 MG 24 HR Extended Release Oral Tablet | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 2585476 | Dyanavel 5 MG 24 HR Extended Release Oral Tablet | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
| 1720592 | Dyanavel XR 2.5 MG per 1 ML 24 HR Extended Release Suspension | SY | ae304b29-0b40-40ec-ad0d-76b742d4a9b9 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 24478-102-01 | 24478010201 | 1 BOTTLE in 1 CARTON (24478-102-01) / 464 mL in 1 BOTTLE | 1 bottle | 2022-07-25 | 0000-00-00 | No | No | Current |
| 24478-102-02 | 24478010202 | 1 BOTTLE in 1 CARTON (24478-102-02) / 60 mL in 1 BOTTLE | 1 bottle | 2026-03-30 | No | No | Current |