NDC 53489-565-01 - 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
- 53489-565
- Requested NDC
- 53489-565-01
- Package NDCs from labels
- 53489-565-01, 53489-565-03, 53489-565-05, 53489-565-10
- 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 |
|---|---|---|---|---|---|---|
| 53489-565-01 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 1 | |
| 53489-565-03 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 250 in 1 BOTTLE, PLASTIC | TABLET | 250 | 1 | |
| 53489-565-05 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 1 | |
| 53489-565-10 | 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 |
|---|---|---|---|---|
| 53489-565 | 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 | Bryant Ranch Prepack | 4804f3e0-2663-44f0-a10e-0baa56df9d69 | 2024-02-07 | Boxed warning, Warnings, Adverse reactions | 1009145 |
| Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Northstar Rx LLC | facdf159-1d95-4981-a8ad-d82edcc14a0c | 2024-01-11 | 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 | Epic Pharma, LLC | 1757e132-061d-4773-89ed-fdc77f69008f | 2023-12-04 | 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 | Camber Pharmaceuticals, Inc. | 430cccec-1679-4225-8c86-92d746153b38 | 2023-09-28 | Boxed warning, Warnings, Adverse reactions | 687043 1009145 541892 577957 541363 541878 577961 |
| 0D9F4440-9ECD-7EF5-D84E-EC41B763CAC4 | F0FC4960-8262-48E1-805C-DAE63FD045B0 | 2007-03-27 | Boxed warning, Warnings, Adverse reactions | 0D9F4440-9ECD-7EF5-D84E-EC41B763CAC4 F0FC4960-8262-48E1-805C-DAE63FD045B0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.