Mixed Salts of a Single-Entity Amphetamine Product
- Product NDC
- 0406-0805
- 11-digit product format
- 004060805
- Labeler code
- 0406
- Product ID
- 0406-0805_03d41c88-9c50-4406-91ba-7a086cad0366
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA211546
- Marketing category
- ANDA
- Marketing start
- 2023-11-01
- Substance
- AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Active strength
- 3.125; 3.125; 3.125; 3.125 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | |
| A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | |
| A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | |
| A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211546-001 | AB2 |
| A211546-002 | AB2 |
| A211546-003 | AB2 |
| A211546-004 | AB2 |
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 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2023-08-31 | 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 | A211546-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211546-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211546-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211546-004 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211546-004 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211546-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211546-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211546-004 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211546-004 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-003 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211546-004 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211546-004 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-003 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211546-004 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-003 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211546-004 | AB2 | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mixed Salts of a Single-Entity Amphetamine Product
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROAMPHETAMINE SULFATE | 3.125 mg/1 |
| DEXTROAMPHETAMINE SACCHARATE | 3.125 mg/1 |
| AMPHETAMINE ASPARTATE MONOHYDRATE | 3.125 mg/1 |
| AMPHETAMINE SULFATE | 3.125 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G83415V073 | Internal UNII lookup |
| JJ768O327N | Internal UNII lookup |
| 6DPV8NK46S | Internal UNII lookup |
| O1ZPV620O4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 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 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 5 | 20230426 |
| 8170729e-5ba4-46f9-830f-5f0fae5942ce | Product name | 1 | 20230103 |
| 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 |
| aa1b3c66-c4f6-78f2-abd3-31cc9d555e27 | Product name | 5 | 20190913 |
| b4c312b9-fad5-247e-cef9-87a74220463d | Product name | 4 | 20171211 |
| 57953747-955c-4dd8-9164-49d8ea877eae | Product name | 1 | 20171113 |
| fcc7ea58-a369-4e91-b092-5cde9ac2669f | Product name | 1 | 20160224 |
| ffdf7f68-0f44-4dd6-a026-336dcb345fc4 | Product name | 1 | 20151109 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-0805-01 | Mixed Salts of a Single-Entity Amphetamine Product | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0406-0805 | MIXED SALTS OF A SINGLE-ENTITY AMPHETAMINE PRODUCT (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE) CAPSULE, EXTENDED RELEASE [SPECGX LLC] | 8 | Current NDC, 1 package rows | 20240724_e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78.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 |
|---|---|---|---|---|---|---|
| Mixed Salts of a Single-Entity Amphetamine Product | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE | SpecGx LLC | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 211546 ANDA211546 0406-0805 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1927610 | amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927630 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927617 | amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927637 | amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule | PSN | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927610 | 3-Bead 24 HR amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG Extended Release Oral Capsule | SCD | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927630 | 3-Bead 24 HR amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG Extended Release Oral Capsule | SCD | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927617 | 3-Bead 24 HR amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG Extended Release Oral Capsule | SCD | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927637 | 3-Bead 24 HR amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG Extended Release Oral Capsule | SCD | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927610 | amphetamine aspartate 12.5 MG / amphetamine sulfate 12.5 MG / dextroamphetamine saccharate 12.5 MG / dextroamphetamine sulfate 12.5 MG 3-Bead 24HR Extended Release Oral Capsule | SY | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927630 | amphetamine aspartate 3.125 MG / amphetamine sulfate 3.125 MG / dextroamphetamine saccharate 3.125 MG / dextroamphetamine sulfate 3.125 MG 3-Bead 24HR Extended Release Oral Capsule | SY | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927617 | amphetamine aspartate 6.25 MG / amphetamine sulfate 6.25 MG / dextroamphetamine saccharate 6.25 MG / dextroamphetamine sulfate 6.25 MG 3-Bead 24HR Extended Release Oral Capsule | SY | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
| 1927637 | amphetamine aspartate 9.375 MG / amphetamine sulfate 9.375 MG / dextroamphetamine saccharate 9.375 MG / dextroamphetamine sulfate 9.375 MG 3-Bead 24HR Extended Release Oral Capsule | SY | e1b21fd4-8d0b-4e54-a35d-8ad84a7caa78 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0406-0805-01 | 00406080501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01) | 2023-11-01 | No | No | Current |