Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Product NDC
- 51407-551
- 11-digit product format
- 514070551
- Labeler code
- 51407
- Product ID
- 51407-551_b5e90203-a411-9dad-e053-2995a90a13bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA212037
- Marketing category
- ANDA
- Marketing start
- 2019-12-11
- Marketing end
- 0000-00-00
- Substance
- DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE
- Active strength
- 5 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
- 2021-12-31
- 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 product | product | 51407-551 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 51407-551 | 51407-551-01 | D | Discontinued by firm | 2026-08-10 |
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 product | product | 51407-551 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 51407-551 | 51407-551-01 | 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 |
|---|---|---|---|---|---|---|---|
| A212037-001 | 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 | 2019-12-11 | |
| A212037-002 | 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 | 2019-12-11 | |
| A212037-003 | 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 | 2019-12-11 | |
| A212037-004 | 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 | 2019-12-11 | |
| A212037-005 | 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 | 2019-12-11 | |
| A212037-006 | 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 | 2019-12-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212037-001 | AB1 |
| A212037-002 | AB1 |
| A212037-003 | AB1 |
| A212037-004 | AB1 |
| A212037-005 | AB1 |
| A212037-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2019-12-11 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212037-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212037-006 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212037-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-005 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212037-006 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-004 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-005 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212037-006 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-005 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212037-006 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-004 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-005 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212037-006 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212037-004 | AB1 | 1 | 2680178bc6a6… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-551-01 | EA - Each | 51407-551 | ae753fa6-3391-4666-9f2b-172796b893d3 | 1 | 2021-01-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51407-551 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.] | 3 | Legacy NDC | 20201209_b56d33c4-5359-e735-e053-2a95a90af67a.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 | Elite Laboratories, Inc. | 084c625c-94c6-4c8a-ba5f-6e26206dd903 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | 212037 ANDA212037 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Burel Pharmaceuticals, LLC | bcdd2fe2-d0de-4a28-aced-40ac9ce5122d | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | 212037 ANDA212037 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51407-551-01 | 51407055101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51407-551-01) | 2020-11-19 | 0000-00-00 | No | No | Current |