Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 62037-727
Methylphenidate hydrochloride 54 mg/1 · Tablet, Film coated, Extended release · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62037-727-01 | 62037072701 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-727-01)Marketed from Mar 4, 2019 |
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)
- Methylphenidate Hydrochloride
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 54 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076655
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 62037-727_24aa9277-3773-489d-8459-f9215140c53fSPL ID 24aa9277-3773-489d-8459-f9215140c53fSPL set ID 85ef422d-af27-4126-9841-6892af1871d6RxCUI 1091155, 1091170, 1091185, 1091210UNII 4B3SC438HI
- 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
N462037072701followed by a unit qualifier and the quantityPackage 62037-0727-01. 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 patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are 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 ) and Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivit…
Excerpt only. Read the full label for complete information.