DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) CII
10b6135f-226e-4422-8048-c4bb74d9719a
HUMAN PRESCRIPTION DRUG LABEL
Mar 2, 2023
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
PRODUCT DETAILS
INGREDIENTS (9)
Drug Labeling Information
DESCRIPTION SECTION
DESCRIPTION
A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.
** EACH TABLET CONTAINS** |
5 mg |
7.5 mg |
10 mg |
12.5 mg |
15 mg |
20 mg |
30 mg |
Dextroamphetamine Saccharate |
1.25 mg |
1.875 mg |
2.5 mg |
3.125 mg |
3.75 mg |
5 mg |
7.5 mg |
Amphetamine Aspartate Monohydrate |
1.25 mg |
1.875 mg |
2.5 mg |
3.125 mg |
3.75 mg |
5 mg |
7.5 mg |
Dextroamphetamine Sulfate, USP |
1.25 mg |
1.875 mg |
2.5 mg |
3.125 mg |
3.75 mg |
5 mg |
7.5 mg |
Amphetamine Sulfate, USP |
1.25 mg |
1.875 mg |
2.5 mg |
3.125 mg |
3.75 mg |
5 mg |
7.5 mg |
Total Amphetamine Base Equivalence |
3.13 mg |
4.7 mg |
6.3 mg |
7.8 mg |
9.4 mg |
12.6 mg |
18.8 mg |
**Inactive Ingredients:**colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (botanical source: maize).
Colors:
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 5 mg, 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake as a color additive.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake as a color additive.