Prescription drug · ANDA
Memantine And Donepezil Hydrochlorides NDC 62559-207
Memantine hydrochloride 21 mg/1; Donepezil hydrochloride 10 mg/1 · Capsule, Extended release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-207-30 | 62559020730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30)Marketed from Jan 1, 2025 |
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)
- Memantine And Donepezil Hydrochlorides
- Generic name (nonproprietary)
- memantine and donepezil hydrochlorides
- Active ingredients
- Memantine hydrochloride — 21 mg/1Donepezil hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208237
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341eSPL ID cd8d0e95-24ac-43e1-9d43-bb081b4f341eSPL set ID c42a995d-cd0f-466c-8f47-43c7f32d9675RxCUI 1805420UNII JY0WD0UA60, 3O2T2PJ89DUPC 0362559207300
- Pharmacologic class
- Cholinesterase Inhibitor; N-methyl-D-aspartate Receptor Antagonist
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
N462559020730followed by a unit qualifier and the quantityPackage 62559-0207-30. 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 .
Indications (excerpt from the label)
Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. ( 1 )
Excerpt only. Read the full label for complete information.