Methylphenidate HCl
- Product NDC
- 39328-154
- 11-digit product format
- 393280154
- Labeler code
- 39328
- Product ID
- 39328-154_604deb17-dd9e-4386-a52b-248b1d5cb6b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Patrin Pharma, Inc.
- Application
- ANDA210764
- Marketing category
- ANDA
- Marketing start
- 2020-04-23
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 mg/5mL
- 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
- Methylphenidate HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091133, 1091341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39328-154-50 | Methylphenidate HCl | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 39328-154 | METHYLPHENIDATE HCL SOLUTION [PATRIN PHARMA, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20200423_7d66dbf9-3966-4949-b7c9-d2ca8c7f3278.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 |
|---|
| 39328-154-50 | 39328015450 | 500 mL in 1 BOTTLE (39328-154-50) | 500 ml | 2020-04-23 | 0000-00-00 | No | No | Current |