Prescription drug · NDA
Focalin (Dexmethylphenidate hydrochloride) NDC 66758-252
Dexmethylphenidate hydrochloride 10 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-252-01 | 66758025201 | 100 TABLET in 1 BOTTLE (66758-252-01)Marketed from Jul 12, 2024 |
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)
- Focalin
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz IncNDC labeler code 66758
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021278
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 66758-252_b5989bf2-41d3-4bd9-82aa-d89923911cd1SPL ID b5989bf2-41d3-4bd9-82aa-d89923911cd1SPL set ID 2016f5c2-95d2-4655-af65-c588c2bf5e6dRxCUI 899518, 899519, 899548, 899549, 899557, 899559UNII 1678OK0E08
- 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
N466758025201followed by a unit qualifier and the quantityPackage 66758-0252-01. 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)
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 66758-252
- What is NDC 66758-252?
- 66758-252 is the product NDC for Focalin (dexmethylphenidate hydrochloride), Dexmethylphenidate hydrochloride 10 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Focalin (Dexmethylphenidate hydrochloride).
- What is the active ingredient?
- Dexmethylphenidate hydrochloride.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Focalin?
- 2 other product NDCs are listed under this name. See all Focalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Focalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Focalindexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 2.5 mg/1 | TabletOral | Sandoz Inc | 66758-250 | 66758-0250-01 |
| Focalindexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Sandoz Inc | 66758-251 | 66758-0251-01 |
Other NDCs under NDA 021278
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 |
|---|---|---|---|---|
| Focalindexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 2.5 mg/1 | TabletOral | Sandoz Inc | 66758-250 |
| Focalindexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Sandoz Inc | 66758-251 |