Prescription drug · ANDA
Dexmethylphenidate hydrochloride NDC 0115-9921
Dexmethylphenidate hydrochloride 20 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-9921-01 | 00115992101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-9921-01)Marketed from Dec 21, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Dexmethylphenidate hydrochloride
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 20 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079108
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 0115-9921_4fcd36f9-1e85-437f-9f27-0e2942480c7fSPL ID 4fcd36f9-1e85-437f-9f27-0e2942480c7fSPL set ID 93e56455-0f15-4ed9-a63a-7fbd0697d520RxCUI 899439, 899461, 899485, 899495, 899511UNII 1678OK0E08UPC 0301159919015, 0301159918018, 0301159921018, 0301159922015, 0301159920011
- 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
N400115992101followed by a unit qualifier and the quantityPackage 00115-9921-01. 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)
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14) ] . Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) , Use in Specific Populations (8.4) ]. Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Atte…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079108
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 |
|---|---|---|---|---|
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9918 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9919 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9920 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-9922 |