Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Product NDC
- 0185-2098
- 11-digit product format
- 001852098
- Labeler code
- 0185
- Product ID
- 0185-2098_9a21fb59-a99c-4c63-91e8-4b5d72fbd9cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA040439
- Marketing category
- ANDA
- Marketing start
- 2002-06-14
- Substance
- AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Active strength
- 1.25; 1.25; 1.25; 1.25 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| O1ZPV620O4 | AMPHETAMINE ASPARTATE MONOHYDRATE | 851591-76-9 | AMPHETAMINE ASPARTATE MONOHYDRATE |
| 6DPV8NK46S | AMPHETAMINE SULFATE | 60-13-9 | AMPHETAMINE SULFATE |
| G83415V073 | DEXTROAMPHETAMINE SACCHARATE | 350708-40-6 | DEXTROAMPHETAMINE SACCHARATE |
| JJ768O327N | DEXTROAMPHETAMINE SULFATE | 51-63-8 | DEXTROAMPHETAMINE SULFATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0185-2098-01 | 00185209801 | 100 TABLET in 1 BOTTLE (0185-2098-01) | 100 tablet | 2021-12-08 | No | No | Historical |