Methylphenidate Hydrochloride
- Product NDC
- 43602-178
- 11-digit product format
- 436020178
- Labeler code
- 43602
- Product ID
- 43602-178_eadd6980-7aad-464b-9ce8-cf7b1a20064d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA207417
- Marketing category
- ANDA
- Marketing start
- 2021-01-29
- Substance
- METHYLPHENIDATE
- 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 Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207ZZ9QZ49 |
| Rxcui | 1091133, 1091341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43602-178-05 | Methylphenidate Hydrochloride | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 3 |
| 43602-178-25 | Methylphenidate Hydrochloride | 250 mL in 1 BOTTLE | SOLUTION | 250 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-178 | METHYLPHENIDATE HYDROCHLORIDE SOLUTION [ASCENT PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20210219_45ebb59c-9603-4df6-b1be-3295ba2db1e7.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 |
|---|
| 43602-178-05 | 43602017805 | 500 mL in 1 BOTTLE (43602-178-05) | 500 ml | 2021-01-29 | 0000-00-00 | No | No | Current |
| 43602-178-25 | 43602017825 | 250 mL in 1 BOTTLE (43602-178-25) | 250 ml | 2021-01-29 | 0000-00-00 | No | No | Current |