Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 72865-124
Methylphenidate hydrochloride 20 mg/1 · Tablet · Oral · XLCare Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-124-01 | 72865012401 | 100 TABLET in 1 BOTTLE (72865-124-01)Marketed from Feb 26, 2020 | |
| 72865-124-05 | 72865012405 | 500 TABLET in 1 BOTTLE (72865-124-05)Marketed from Feb 26, 2020 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207416
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 72865-124_0a38c200-2e90-42b8-97e8-e5b64a7078e0SPL ID 0a38c200-2e90-42b8-97e8-e5b64a7078e0SPL set ID 94dc74d4-b4ef-45bc-b502-54ec692e9bd5RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HIUPC 0372865124017, 0372865123010, 0372865122013
- 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
N472865012401followed by a unit qualifier and the quantityPackage 72865-0124-01. 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)
1. INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Excerpt only. Read the full label for complete information.