Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 31722-175
Methylphenidate hydrochloride 20 mg/1 · Tablet · Oral · Camber Pharmaceutical Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-175-01 | 31722017501 | 100 TABLET in 1 BOTTLE (31722-175-01)Marketed from Oct 1, 2015 | |
| 31722-175-05 | 31722017505 | 500 TABLET in 1 BOTTLE (31722-175-05)Marketed from Oct 1, 2015 |
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
- Camber Pharmaceutical 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 31722-175_85610552-360d-4ae3-b160-0819534f8220SPL ID 85610552-360d-4ae3-b160-0819534f8220SPL set ID 778190da-1528-4def-94bf-ee23ee5268a5RxCUI 1091150, 1091392, 1091497UNII 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
N431722017501followed by a unit qualifier and the quantityPackage 31722-0175-01. 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.
Other NDCs under ANDA 207416
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 5 mg/1 | TabletOral | Camber Pharmaceutical Inc | 31722-173 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceutical Inc | 31722-174 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | TabletOral | XLCare Pharmaceuticals Inc | 72865-122 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | XLCare Pharmaceuticals Inc | 72865-123 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | TabletOral | XLCare Pharmaceuticals Inc | 72865-124 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1219 |