Methylphenidate Hydrochloride
- Product NDC
- 0115-1741
- 11-digit product format
- 001151741
- Labeler code
- 0115
- Product ID
- 0115-1741_a1946373-6df9-4fd8-8c10-3d8d8b6ad9ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA205105
- Marketing category
- ANDA
- Marketing start
- 2016-09-20
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 60 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
- Methylphenidate Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1806181, 1806187, 1806189, 1806191, 1806193, 1806197 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1741-01 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1741 | METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231122_10aa0dc0-bd0e-4927-a19a-8722d78ad67d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1741-01 | 00115174101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1741-01) | 2016-09-20 | 0000-00-00 | No | No | Current |