Prescription drug · NDA
Cotempla XR-ODT (Methylphenidate) NDC 70165-100
Methylphenidate 8.6 mg/1 · Tablet, Orally disintegrating · Oral · Neos Therapeutics Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70165-100-30 | 7016501003070165010030 | 5 BLISTER PACK in 1 CARTON (70165-100-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jun 20, 2017 | |
| 70165-100-31 | 7016501003170165010031 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70165-100-31)Marketed from Oct 12, 2026 |
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 — 8.6 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Neos Therapeutics Brands, LLCNDC labeler code 70165
- 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 70165-100_5190dd03-32d1-27f9-e063-6294a90ae1d8SPL ID 5190dd03-32d1-27f9-e063-6294a90ae1d8
- 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
N470165010030followed by a unit qualifier and the quantityPackage 70165-0100-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70165-100
- What is NDC 70165-100?
- 70165-100 is the product NDC for Cotempla XR-ODT (methylphenidate), Methylphenidate 8.6 mg/1 tablet, orally disintegrating, listed with the FDA by Neos Therapeutics Brands, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cotempla XR-ODT (Methylphenidate).
- What is the active ingredient?
- Methylphenidate.
- Who is the labeler?
- Neos Therapeutics Brands, LLC, NDC labeler code 70165. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cotempla XR-ODT?
- 2 other product NDCs are listed under this name. See all Cotempla XR-ODT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cotempla XR-ODT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cotempla XR-ODTmethylphenidate | Methylphenidate 17.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-200 | 70165-0200-3070165-0200-31 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 25.9 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-300 | 70165-0300-3070165-0300-31 |
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 |
|---|---|---|---|---|
| Cotempla XR-ODTmethylphenidate | Methylphenidate 17.3 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-200 |
| Cotempla XR-ODTmethylphenidate | Methylphenidate 25.9 mg/1 | Tablet, Orally disintegratingOral | Neos Therapeutics Brands, LLC | 70165-300 |
| 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 |