Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 64980-222
Methylphenidate hydrochloride 5 mg/1 · Tablet, Chewable · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-222-01 | 64980022201 | 100 TABLET, CHEWABLE in 1 BOTTLE (64980-222-01)Marketed from Dec 18, 2018 |
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 — 5 mg/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205756
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 64980-222_85d614b0-888e-461f-bc7d-3f240ed8bd0eSPL ID 85d614b0-888e-461f-bc7d-3f240ed8bd0eSPL set ID e5cb0740-813f-4dce-8c29-d7680c66e77cRxCUI 1091152, 1091322, 1091389UNII 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
N464980022201followed by a unit qualifier and the quantityPackage 64980-0222-01. 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 Chewable Tablets is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older Narcolepsy Methylphenidate Hydrochloride Chewable Tablets are a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205756
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 | Methylphenidate hydrochloride 2.5 mg/1 | Tablet, ChewableOral | Rising Pharma Holdings, Inc. | 64980-221 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Tablet, ChewableOral | Rising Pharma Holdings, Inc. | 64980-223 |