DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Product NDC
- 43602-320
- Requested package NDC
- 43602-320-05
- 11-digit product format
- 436020320
- Labeler code
- 43602
- Product ID
- 43602-320_d83a3b23-e47e-4f28-9e87-8a0a7e1b127a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc
- Application
- ANDA214959
- Marketing category
- ANDA
- Marketing start
- 2021-09-29
- Marketing end
- 0000-00-00
- Substance
- DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
- Active strength
- 6 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 43602-320 | 43602-320-05 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 43602-320 | 43602-320-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | |
| A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | |
| A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | |
| A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | |
| A214959-005 | 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 | AB1 | 2021-09-29 | |
| A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214959-001 | AB1 |
| A214959-002 | AB1 |
| A214959-003 | AB1 |
| A214959-004 | AB1 |
| A214959-005 | AB1 |
| A214959-006 | AB1 |
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 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2021-09-29 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214959-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214959-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214959-003 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214959-004 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214959-005 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214959-006 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214959-006 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214959-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-005 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214959-006 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-004 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-005 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214959-006 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-005 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214959-006 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214959-004 | AB1 | 1 | 03ed91905a0d… |
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 Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43602-320 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC] | 2 | Legacy NDC | 20211008_d91c8624-8002-4f03-ad26-deb195be4e09.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 |
|---|---|---|---|---|---|---|
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Camber Pharmaceuticals, Inc. | 1fc35735-569c-4dcd-b6c6-14443a043de5 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | 214959 ANDA214959 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43602-320-05 | 43602032005 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-320-05) | 2021-09-29 | 0000-00-00 | No | No | Current |