Dextroamphetamine Sulfate
- Product NDC
- 68382-943
- 11-digit product format
- 683820943
- Labeler code
- 68382
- Product ID
- 68382-943_7a16d81a-a695-478a-9eb1-f09843699173
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA209111
- Marketing category
- ANDA
- Marketing start
- 2017-06-28
- Marketing end
- 0000-00-00
- Substance
- DEXTROAMPHETAMINE SULFATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-943-01 | Dextroamphetamine Sulfate | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-943 | DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC. ] | 8 | Legacy NDC, 1 package rows | 20211218_124c91d5-b533-4caa-aa14-81f1dba9fa90.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-943-01 | 68382094301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-943-01) | 2017-06-28 | 0000-00-00 | No | No | Current |