Dextroamphetamine Sulfate
- Product NDC
- 27808-089
- 11-digit product format
- 278080089
- Labeler code
- 27808
- Product ID
- 27808-089_97577638-7333-40a8-87d8-f426b7ee7672
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA206095
- Marketing category
- ANDA
- Marketing start
- 2022-08-20
- 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
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JJ768O327N |
| Rxcui | 884385, 884386 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27808-089-01 | Dextroamphetamine Sulfate | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-089 | DEXTROAMPHETAMINE SULFATE TABLET [TRIS PHARMA INC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20231024_9acdf000-fefe-47c7-a44c-0f7a65c5c05c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 27808-089-01 | 27808008901 | 100 TABLET in 1 BOTTLE, PLASTIC (27808-089-01) | 100 tablet | 2023-02-28 | No | No | Historical |