Prescription drug · ANDA
Methylphenidate NDC 0378-8260
Methylphenidate 1.1 mg/h · Patch · Transdermal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8260-93 | 0037882609300378826093 | 30 POUCH in 1 CARTON (0378-8260-93) / 1 PATCH in 1 POUCH (0378-8260-16) / 9 h in 1 PATCHMarketed from Jun 27, 2022 |
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
- Generic name (nonproprietary)
- methylphenidate
- Active ingredients
- Methylphenidate — 1.1 mg/h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206497
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0378-8260_c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535SPL ID c5b3220c-d8cc-42a7-a0e8-3cc1ccc3d535SPL set ID 1643b6a5-80da-4d4f-8c5f-feb907875702RxCUI 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
N400378826093followed by a unit qualifier and the quantityPackage 00378-8260-93. 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 is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Us e 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 Hyperactivity Disorder (ADHD) in pediatric pa…
Excerpt only. Read the full label for complete information.
About NDC 0378-8260
- What is NDC 0378-8260?
- 0378-8260 is the product NDC for Methylphenidate, Methylphenidate 1.1 mg/h patch, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylphenidate.
- What is the active ingredient?
- Methylphenidate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylphenidate?
- 13 other product NDCs are listed under this name. See all Methylphenidate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylphenidate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylphenidate | Methylphenidate 1.6 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8261 | 00378-8261-93 |
| Methylphenidate | Methylphenidate 2.2 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8262 | 00378-8262-93 |
| Methylphenidate | Methylphenidate 3.3 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8263 | 00378-8263-93 |
| Methylphenidatemethylphenidate hydrochloride | Methylphenidate hydrochloride 5 mg/5mL | SolutionOral | KVK-Tech, Inc. | 10702-163 | 10702-0163-50 |
| Methylphenidatemethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/5mL | SolutionOral | KVK-Tech, Inc. | 10702-164 | 10702-0164-50 |
| Methylphenidate | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2361 | — |
| Methylphenidate | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2362 | 00781-2362-01 |
| Methylphenidate | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2363 | 00781-2363-01 |
| Methylphenidate | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2364 | 00781-2364-01 |
| Methylphenidate | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2383 | 00781-2383-01 |
Other NDCs under ANDA 206497
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 | Methylphenidate 1.6 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8261 |
| Methylphenidate | Methylphenidate 2.2 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8262 |
| Methylphenidate | Methylphenidate 3.3 mg/h | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-8263 |