Prescription drug · NDA
Daytrana (Methylphenidate) NDC 68968-5553
Methylphenidate 15 mg/9h · Patch · Transdermal · Noven Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68968-5553-3 | 6896855530368968555303 | 30 PATCH in 1 CARTON (68968-5553-3) / 9 h in 1 PATCHMarketed from Apr 6, 2006 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Daytrana
- Generic name (nonproprietary)
- methylphenidate
- Active ingredients
- Methylphenidate — 15 mg/9h
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Noven Therapeutics, LLCNDC labeler code 68968
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021514
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 68968-5553_55f4b5f4-6d3c-4677-a94c-d47ffb59a91aSPL ID 55f4b5f4-6d3c-4677-a94c-d47ffb59a91aSPL set ID 2c312c31-3198-4775-91ab-294e0b4b9e7fRxCUI 753436, 753437, 753438, 753439, 753440, 753441, 753442, 753443UNII 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
N468968555303followed by a unit qualifier and the quantityPackage 68968-5553-03. 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)
DAYTRANA (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 DAYTRANA 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 )] . DAYTRANA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limit…
Excerpt only. Read the full label for complete information.
About NDC 68968-5553
- What is NDC 68968-5553?
- 68968-5553 is the product NDC for Daytrana (methylphenidate), Methylphenidate 15 mg/9h patch, listed with the FDA by Noven Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daytrana (Methylphenidate).
- What is the active ingredient?
- Methylphenidate.
- Who is the labeler?
- Noven Therapeutics, LLC, NDC labeler code 68968. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daytrana?
- 3 other product NDCs are listed under this name. See all Daytrana NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Daytrana products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Daytranamethylphenidate | Methylphenidate 10 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5552 | 68968-5552-03 |
| Daytranamethylphenidate | Methylphenidate 20 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5554 | 68968-5554-03 |
| Daytranamethylphenidate | Methylphenidate 30 mg/9h | PatchTransdermal | Noven Therapeutics, LLC | 68968-5555 | 68968-5555-03 |
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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Methylphenidate Transdermal Systemmethylphenidate | Methylphenidate 82.5 mg/mg | PatchTransdermal | PADAGIS US LLC | 0574-2430 |