Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 57664-228
Methylphenidate hydrochloride 5 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-228-08 | 57664022808 | 100 TABLET in 1 BOTTLE (57664-228-08)Marketed from Aug 16, 2013 | |
| 57664-228-13 | 57664022813 | 500 TABLET in 1 BOTTLE (57664-228-13)Marketed from Aug 16, 2013 | |
| 57664-228-18 | 57664022818 | 1000 TABLET in 1 BOTTLE (57664-228-18)Marketed from Aug 16, 2013 | |
| 57664-228-83 | 57664022883 | 30 TABLET in 1 BOTTLE (57664-228-83)Marketed from Aug 16, 2013 | |
| 57664-228-88 | 57664022888 | 100 TABLET in 1 BOTTLE (57664-228-88)Marketed from Aug 16, 2013 |
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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090710
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 57664-228_2f1c1df8-491a-08c9-e063-6394a90a1d06SPL ID 2f1c1df8-491a-08c9-e063-6394a90a1d06SPL set ID 1a89b390-0cd5-45cb-9e70-20de44652c56RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HIUPC 0357664228883, 0357664229880, 0357664230886
- 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
N457664022808followed by a unit qualifier and the quantityPackage 57664-0228-08. 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 tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride tablets are 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 090710
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 | Bryant Ranch Prepack | 63629-1172 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1636 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-229 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-230 |