Dexmethylphenidate hydrochloride
- Product NDC
- 75834-327
- 11-digit product format
- 758340327
- Labeler code
- 75834
- Product ID
- 75834-327_6103914c-da93-4648-9180-e5c439a07bc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA209211
- Marketing category
- ANDA
- Marketing start
- 2024-05-03
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmethylphenidate hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1678OK0E08 |
| Rxcui | 899518, 899548 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-327-01 | Dexmethylphenidate hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-327 | DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240503_638f614c-bf91-4bf6-876f-bf25fa273bc4.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 |
|---|
| 75834-327-01 | 75834032701 | 100 TABLET in 1 BOTTLE (75834-327-01) | 100 tablet | 2024-05-03 | No | No | Current |