Methylphenidate Transdermal System
- Product NDC
- 0574-2430
- 11-digit product format
- 005742430
- Labeler code
- 0574
- Product ID
- 0574-2430_b743ef45-2fc0-4086-8a02-6078e6a09eaa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- PADAGIS US LLC
- Application
- NDA021514
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-06-05
- Substance
- METHYLPHENIDATE
- Active strength
- 82.5 mg/mg
- 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 Transdermal System
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE | 82.5 mg/mg |
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 |
|---|
| 0574-2430-65 | Methylphenidate Transdermal System | 30 in 1 TRAY | PATCH | 30 | | 7 |
| 0574-2430-65 | Methylphenidate Transdermal System | 1 in 1 CARTON | PATCH | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-2430 | METHYLPHENIDATE TRANSDERMAL SYSTEM (METHYLPHENIDATE) PATCH [PADAGIS US LLC] | 5 | Current NDC, 2 package rows | 20241212_7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0574-2430-65 | 00574243065 | 1 TRAY in 1 CARTON (0574-2430-65) / 30 POUCH in 1 TRAY / 1 PATCH in 1 POUCH / 82.5 mg in 1 PATCH | 1 tray | 2023-06-05 | No | No | Historical |