Methylphenidate
- Product NDC
- 0378-8260
- 11-digit product format
- 003788260
- Labeler code
- 0378
- Product ID
- 0378-8260_c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA206497
- Marketing category
- ANDA
- Marketing start
- 2022-06-27
- Marketing end
- 2027-04-30
- Substance
- METHYLPHENIDATE
- Active strength
- 1.1 mg/h
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE | 1.1 mg/h |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207ZZ9QZ49 |
| Rxcui | 753436, 753438, 753440, 753441 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8260-16 | Methylphenidate | 1 in 1 POUCH | PATCH | 1 | | 6 |
| 0378-8260-16 | Methylphenidate | 9 h in 1 PATCH | PATCH | 9 | | 6 |
| 0378-8260-93 | Methylphenidate | 30 in 1 CARTON | PATCH | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8260 | METHYLPHENIDATE PATCH [MYLAN PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20250330_1643b6a5-80da-4d4f-8c5f-feb907875702.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 |
|---|
| 0378-8260-16 | 00378826016 | 1 in 1 POUCH | | | | | | Historical |
| 0378-8260-93 | 00378826093 | 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCH | 30 pouch | 2022-06-27 | 2027-04-30 | No | No | Current |