NDC 53489-570-01 - Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 53489-570
- Requested NDC
- 53489-570-01
- Package NDCs from labels
- 53489-570-01, 53489-570-03, 53489-570-05, 53489-570-10
- Manufacturer
- Mutual Pharmaceutical Company
- Effective date
- 2007-03-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Dextroamphetamine Saccharate - Mutual Pharmaceutical Company | Mutual Pharmaceutical Company | 2007-03-27 | HUMAN PRESCRIPTION DRUG LABELING |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53489-570-01 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 1 | |
| 53489-570-03 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 250 in 1 BOTTLE, PLASTIC | TABLET | 250 | 1 | |
| 53489-570-05 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 1 | |
| 53489-570-10 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53489-570 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE) TABLET [MUTUAL PHARMACEUTICAL COMPANY] | 1 | 4 package rows | 20070517_F0FC4960-8262-48E1-805C-DAE63FD045B0.zip |
DailyMed Socrata Ingredients#
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, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | SUNRISE PHARMACEUTICAL, INC. | ac102599-3a5b-4154-899e-6ff262be7ff7 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Aurolife Pharma, LLC | a582d57f-d191-4ca5-b105-585b2d8a0e3e | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Oryza Pharmaceuticals Inc. | acd27181-a3f3-4c38-85d8-029a4a82e7c2 | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Lannett Company, LLC | f92497b5-baea-4760-b615-45a0b6184402 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Granules Pharmaceuticals Inc. | b0b4eccc-34c7-483d-966f-82d588358e1b | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Elite Laboratories, Inc. | e677690f-790f-4626-ad78-097cdb6ea540 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | ff1e5518-0aa6-4bc9-bc87-8a6a124bc95a | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 541363 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Rhodes Pharmaceuticals LLC | ef3590cc-49ae-44f7-85a9-7c11f58d467e | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE | GLENMARK PHARMACEUTICALS INC., USA | 4564e404-8d71-4585-ab78-55857f477143 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | NorthStar RxLLC | 8468623b-9584-43ef-ac16-fc15b060624c | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE AND AMPHETAMINE ASPARTATE AND DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | SpecGx LLC | 72ddd1c9-ddbd-4c95-acd9-003189a353a3 | 2025-11-25 | Boxed warning, Warnings, Adverse reactions | 1009145 541892 577957 541363 541878 577961 |
| Adderall | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Teva Pharmaceuticals USA, Inc. | f22635fe-821d-4cde-aa12-419f8b53db81 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Teva Pharmaceuticals USA, Inc. | cffbbb15-d776-41ae-a8a6-687f2c07bfa4 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | c0fe49d9-be68-47cb-9c43-597144a92a14 | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | 541363 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | b8ed12f7-7532-4e43-9fa9-d5a217b5661d | 2024-05-17 | Boxed warning, Warnings, Adverse reactions | 541892 |
| Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Sun Pharmaceutical Industries, Inc. | 9af67219-9b37-45d0-ac52-647cbfacd296 | 2024-05-02 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Sandoz Inc | 288dafc4-fe6e-4891-832f-511022c87445 | 2024-04-24 | Boxed warning, Warnings, Adverse reactions | 541892 541363 541878 577961 |
| Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | b90efc87-f328-4501-b7bb-d059ac501f7f | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 541892 |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | 09a109a6-6cfc-4f20-a958-90f0fe386bf5 | 2024-02-08 | Boxed warning, Warnings, Adverse reactions | 577961 |
| DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE | Bryant Ranch Prepack | 00a0961d-b9f8-4be5-8ebf-9bd024cbe029 | 2024-02-07 | Boxed warning, Warnings, Adverse reactions | 687043 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.