Amphetamine Sulfate
- Product NDC
- 69292-106
- 11-digit product format
- 692920106
- Labeler code
- 69292
- Product ID
- 69292-106_5720f138-6dc8-ebc4-e063-6294a90a9c11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma, Inc.
- Application
- ANDA212901
- Marketing category
- ANDA
- Marketing start
- 2026-06-15
- Substance
- AMPHETAMINE SULFATE
- Active strength
- 5 mg/1
- 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 |
|---|---|---|---|---|---|---|---|
| A212901-001 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | |
| A212901-002 | AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212901-001 | AA |
| A212901-002 | AA |
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 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212901-001 | AMPHETAMINE SULFATE | 5MG | TABLET / ORAL | AA | 2020-05-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212901-002 | AMPHETAMINE SULFATE | 10MG | TABLET / ORAL | AA | 2020-05-22 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212901-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212901-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212901-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212901-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212901-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212901-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212901-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212901-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212901-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212901-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212901-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212901-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212901-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212901-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212901-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212901-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212901-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212901-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212901-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212901-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212901-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212901-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212901-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212901-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212901-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212901-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212901-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212901-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212901-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212901-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212901-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212901-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212901-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212901-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212901-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212901-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212901-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212901-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212901-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212901-002 | AA | 1 | bb7c543d1eb4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amphetamine Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPHETAMINE SULFATE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6DPV8NK46S | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e045dc28-e05d-4407-9d44-d0a11ca558e6 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Amici Pharma, Inc. | e045dc28-e05d-4407-9d44-d0a11ca558e6 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 69292-106 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 9817a519-fdb0-474a-92f4-2e485c9cb047 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 9eb84b3c-2147-42dd-8053-6afd1a88b0c1 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 3ad894e3-78a7-4e3b-80d1-1a925fb6d9e3 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | 698171ee-4328-476a-b71c-58aa6dc93b23 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Bryant Ranch Prepack | c00bbade-3dc8-422b-8cff-f85db408bdfc | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
| AMPHETAMINE SULFATE | AMPHETAMINE SULFATE | Lannett Company, Inc. | 85a015a7-a1a0-4b04-8bc4-7aacd0c84742 | 2024-01-19 | Boxed warning, Warnings, Adverse reactions | 212901 ANDA212901 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69292-106-01 | 69292010601 | 100 TABLET in 1 BOTTLE (69292-106-01) | 100 tablet | 2026-06-15 | No | No | Current |