Amphetamine Sulfate
- Product NDC
- 13107-259
- 11-digit product format
- 131070259
- Labeler code
- 13107
- Product ID
- 13107-259_992a765b-f8cb-4311-b25a-053c11a90bab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphetamine Sulfate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma, LLC
- Application
- ANDA211639
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Substance
- AMPHETAMINE 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
- Amphetamine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMPHETAMINE SULFATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6DPV8NK46S |
| Rxcui | 884655, 1600695 |
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 |
|---|
| 13107-259-01 | Amphetamine Sulfate | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-259 | AMPHETAMINE SULFATE TABLET [AUROLIFE PHARMA, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240201_20735c2e-6304-425f-a4e4-584f6f90d6a0.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 |
|---|
| 13107-259-01 | 13107025901 | 100 TABLET in 1 BOTTLE (13107-259-01) | 100 tablet | 2019-01-31 | 0000-00-00 | No | No | Current |