Methylphenidate
- Product NDC
- 0781-2383
- 11-digit product format
- 007812383
- Labeler code
- 0781
- Product ID
- 0781-2383_ade65b90-a3e4-4df4-a066-b72f161dc306
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- NDA021284
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-11-24
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1806177, 1806179, 1806183, 1806195 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-2383-01 | Methylphenidate | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-2383 | METHYLPHENIDATE CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 2 | Current NDC, 1 package rows | 20250313_44386394-d2a3-4483-abe1-6c5c634cc501.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-2383-01 | 00781238301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2383-01) | 2025-03-03 | No | No | Historical |