Prescription drug · NDA AUTHORIZED GENERIC
Methylphenidate Transdermal System NDC 0574-2430
methylphenidate · Methylphenidate 82.5 mg/mg · Patch · Transdermal · PADAGIS US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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 PATCHMarketed from Jun 5, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methylphenidate Transdermal System
- Generic name (nonproprietary)
- methylphenidate
- Active ingredients
- Methylphenidate — 82.5 mg/mg
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- PADAGIS US LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021514
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0574-2430_b743ef45-2fc0-4086-8a02-6078e6a09eaaSPL ID b743ef45-2fc0-4086-8a02-6078e6a09eaaSPL set ID 7bcff873-1fc2-45bc-a8e4-5db4edeb9bfbRxCUI 753436, 753438, 753440, 753441UNII 207ZZ9QZ49
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400574243065followed by a unit qualifier and the quantityPackage 00574-2430-65. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Methylphenidate Transdermal System (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use The use of Methylphenidate Transdermal System is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.4 )] . Methylphenidate Transdermal System is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperac…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021514
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methylphenidate Transdermal Systemmethylphenidate | Methylphenidate 27.5 mg/mg | PatchTransdermal | PADAGIS US LLC | 0574-2410 |
| Methylphenidate Transdermal Systemmethylphenidate | Methylphenidate 41.3 mg/mg | PatchTransdermal | PADAGIS US LLC | 0574-2415 |
| Methylphenidate Transdermal Systemmethylphenidate | Methylphenidate 55 mg/mg | PatchTransdermal | PADAGIS US LLC | 0574-2420 |
| Daytranamethylphenidate | Methylphenidate 15 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5553 |
| Daytranamethylphenidate | Methylphenidate 10 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5552 |
| Daytranamethylphenidate | Methylphenidate 20 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5554 |
| Daytranamethylphenidate | Methylphenidate 30 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5555 |