Prescription drug · ANDA
Methylphenidate Hydrochloride Extended-Release (Methylphenidate hydrochloride) NDC 0406-0127
Methylphenidate hydrochloride 27 mg/1 · Tablet, Extended release · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-0127-01 | 00406012701 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-0127-01)Marketed from Dec 28, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Methylphenidate Hydrochloride Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 27 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202608
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0406-0127_24d8e2c3-6e4d-44b8-aafe-7c713b11af5aSPL ID 24d8e2c3-6e4d-44b8-aafe-7c713b11af5aSPL set ID b1b0f2ff-d9df-42ab-b471-226ecf97e075RxCUI 2001565, 2001566, 2001568UNII 4B3SC438HIUPC 0304060154018, 0304060136014, 0304060127012
- 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
N400406012701followed by a unit qualifier and the quantityPackage 00406-0127-01. 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)
Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies ( 14 )] . Methylphenidate hydrochloride extended-release tablets USP are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0406-0127
- What is NDC 0406-0127?
- 0406-0127 is the product NDC for Methylphenidate Hydrochloride Extended-Release, Methylphenidate hydrochloride 27 mg/1 tablet, extended release, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylphenidate Hydrochloride Extended-Release (Methylphenidate Hydrochloride).
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylphenidate Hydrochloride Extended-Release?
- 10 other product NDCs are listed under this name. See all Methylphenidate Hydrochloride Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylphenidate Hydrochloride Extended-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1810 | 00406-1810-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1820 | 00406-1820-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1830 | 00406-1830-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1840 | 00406-1840-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 50 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1850 | 00406-1850-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | SpecGx LLC | 0406-1860 | 00406-1860-01 |
| Methylphenidate Hydrochloride Extended Release | Methylphenidate hydrochloride 10 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-075 | 10702-0075-0110702-0075-06 |
| Methylphenidate Hydrochloride Extended Release | Methylphenidate hydrochloride 20 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-076 | 10702-0076-0110702-0076-06 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0136 | 00406-0136-01 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0154 | 00406-0154-01 |
Other NDCs under ANDA 202608
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 Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0136 |
| Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | SpecGx LLC | 0406-0154 |