Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 27808-058
Methylphenidate hydrochloride 5 mg/5mL · Solution · Oral · Cranbury Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 27808-058-01 | 27808005801 | 500 mL in 1 BOTTLE, PLASTIC (27808-058-01)Marketed from Mar 4, 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 — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091601
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 27808-058_2b5b76ed-a330-4f7b-a111-467a067ee663SPL ID 2b5b76ed-a330-4f7b-a111-467a067ee663SPL set ID e817377f-bc72-415a-acd2-7136746b2479RxCUI 1091133, 1091341UNII 4B3SC438HIUPC 0327808059017
- 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
N427808005801followed by a unit qualifier and the quantityPackage 27808-0058-01. 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 oral solution is indicated for the treatment of: • Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older • Narcolepsy Methylphenidate hydrochloride oral solution is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091601
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/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2040 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/5mL | SolutionOral | Bryant Ranch Prepack | 72162-2041 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/5mL | SolutionOral | Cranbury Pharmaceuticals, LLC | 27808-059 |