Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Product NDC
- 71335-2070
- 11-digit product format
- 713352070
- Labeler code
- 71335
- Product ID
- 71335-2070_5ec79e91-e561-4338-9fc6-299a172bfefe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040439
- Marketing category
- ANDA
- Marketing start
- 2002-06-14
- Substance
- AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Active strength
- 7.5; 7.5; 7.5; 7.5 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
openFDA Listing Details
- Product ID
- 71335-2070_5ec79e91-e561-4338-9fc6-299a172bfefe
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Generic name
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2002-06-14
- Marketing category
- ANDA
- Application number
- ANDA040439
- Pharmacologic classes
- Central Nervous System Stimulant [EPC]; Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMPHETAMINE ASPARTATE MONOHYDRATE | 7.5 mg/1 |
| AMPHETAMINE SULFATE | 7.5 mg/1 |
| DEXTROAMPHETAMINE SACCHARATE | 7.5 mg/1 |
| DEXTROAMPHETAMINE SULFATE | 7.5 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | O1ZPV620O4, 6DPV8NK46S, G83415V073, JJ768O327N |
| Rxcui | 541363 |
| Spl Set Id | c0fe49d9-be68-47cb-9c43-597144a92a14 |
| Manufacturer Name | Bryant Ranch Prepack |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-2070-1 | 71335207001 | 60 TABLET in 1 BOTTLE (71335-2070-1) | 60 tablet | 2022-04-25 | 0000-00-00 | No | No | Current |
| 71335-2070-2 | 71335207002 | 90 TABLET in 1 BOTTLE (71335-2070-2) | 90 tablet | 2022-04-25 | 0000-00-00 | No | No | Current |
| 71335-2070-3 | 71335207003 | 30 TABLET in 1 BOTTLE (71335-2070-3) | 30 tablet | 2022-04-25 | 0000-00-00 | No | No | Current |