Dextroamphetamine Sulfate
- Product NDC
- 75826-125
- 11-digit product format
- 758260125
- Labeler code
- 75826
- Product ID
- 75826-125_37ddfa9e-e495-a25f-e063-6394a90ac3d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Winder Laboratories LLC
- Application
- ANDA212160
- Marketing category
- ANDA
- Marketing start
- 2021-12-06
- Substance
- DEXTROAMPHETAMINE SULFATE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dextroamphetamine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROAMPHETAMINE SULFATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JJ768O327N |
| Rxcui | 884385, 884386, 884684, 1425847, 1425854, 1535454, 1535470 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75826-125-10 | Dextroamphetamine Sulfate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 11 |
| 75826-125-30 | Dextroamphetamine Sulfate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75826-125 | DEXTROAMPHETAMINE SULFATE TABLET [WINDER LABORATORIES LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240814_ca1a8890-0675-4c9c-9716-6c28f975d827.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75826-125-10 | 75826012510 | 100 TABLET in 1 BOTTLE, PLASTIC (75826-125-10) | 100 tablet | 2023-03-24 | 0000-00-00 | No | No | Current |
| 75826-125-30 | 75826012530 | 30 TABLET in 1 BOTTLE, PLASTIC (75826-125-30) | 30 tablet | 2023-03-24 | 0000-00-00 | No | No | Current |