Prescription drug · NDA
Focalin XR (Dexmethylphenidate hydrochloride) NDC 0078-0430
Dexmethylphenidate hydrochloride 5 mg/1 · Capsule, Extended release · Oral · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0078-0430Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00078-0430Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Focalin XRSuffix: XR
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 5 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021802
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0078-0430_fd5dd3b3-6bdf-437e-a763-1a07f9631121SPL ID fd5dd3b3-6bdf-437e-a763-1a07f9631121SPL set ID 1a1da905-42a0-4748-9c39-67eca45decccRxCUI 899439, 899441, 899461, 899463, 899485, 899487, 899495, 899497, 899511, 899513, 1006608, 1006610, 1101926, 1101928, 1101932, 1101934UNII 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Limitations of Use The use of Focalin XR 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 )]. Focalin XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ). Limitations of Use The use of Focalin XR is not recommended in pediatric patients younger th…
Excerpt only. Read the full label for complete information.
About NDC 0078-0430
- What is NDC 0078-0430?
- 0078-0430 is the product NDC for Focalin XR (dexmethylphenidate hydrochloride), Dexmethylphenidate hydrochloride 5 mg/1 capsule, extended release, listed with the FDA by Novartis Pharmaceuticals Corporation.
- What drug is associated with this NDC?
- Focalin XR (Dexmethylphenidate hydrochloride).
- What is the active ingredient?
- Dexmethylphenidate hydrochloride.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. 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 XR?
- 15 other product NDCs are listed under this name. See all Focalin XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Focalin XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0434 | — |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0608 | — |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0609 | — |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0493 | — |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0432 | 00078-0432-05 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0433 | 00078-0433-05 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-235 | 66758-0235-0166758-0235-31 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-238 | 66758-0238-0166758-0238-31 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-236 | 66758-0236-0166758-0236-31 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-237 | 66758-0237-0166758-0237-31 |
Other NDCs under NDA 021802
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 |
|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2729 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0432 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2730 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0608 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0493 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-235 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-236 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-237 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-238 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-239 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-240 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-241 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 66758-242 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0433 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0609 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0431 |
| Focalin XRdexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Novartis Pharmaceuticals Corporation | 0078-0434 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2727 |
| Dexmethylphenidate Hydrochloride Extended-Releasedexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Sandoz Inc | 0781-2728 |