dextroamphetamine sulfate
- Product NDC
- 51862-346
- 11-digit product format
- 518620346
- Labeler code
- 51862
- Product ID
- 51862-346_348dccbd-c876-417c-a849-0059aec5516c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dextroamphetamine sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA203901
- Marketing category
- ANDA
- Marketing start
- 2016-08-05
- Marketing end
- 0000-00-00
- Substance
- DEXTROAMPHETAMINE SULFATE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51862-346-90 | 51862034690 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51862-346-90) | 2016-08-05 | 0000-00-00 | No | No | Current |