Prescription drug · NDA
Cotempla XR-ODT (methylphenidate) NDC 70165-300
Methylphenidate 25.9 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70165-300-30 | 70165030030 | 5 BLISTER PACK in 1 CARTON (70165-300-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 20, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Cotempla XR-ODT
- Generic name (nonproprietary)
- methylphenidate
- Active ingredients
- Methylphenidate — 25.9 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205489
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70165-300_3f8e1342-96a7-1d02-e063-6394a90a3903SPL ID 3f8e1342-96a7-1d02-e063-6394a90a3903SPL set ID 33f70f58-c871-42c8-8adb-345caeafefcdRxCUI 1926840, 1926847, 1926849, 1926851, 1926853, 1926855UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470165030030followed by a unit qualifier and the quantityPackage 70165-0300-30. 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)
COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ]. Limitations of Use The use of COTEMPLA XR-ODT 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 (5.7). Use in Specific Populations (8.4)] . COTEMPLA XR-ODT 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. ( …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205489
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 Extended-Release | Methylphenidate 8.6 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-100 |
| Methylphenidate Extended-Release | Methylphenidate 17.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-250 |
| Methylphenidate Extended-Release | Methylphenidate 25.9 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics, LP | 62542-350 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 8.6 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-100 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 17.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-200 |