Prescription drug · ANDA
memantine hydrochloride (memantine) NDC 65162-169
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-169-06 | 65162016906 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-169-06)Marketed from Mar 24, 2022 |
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 hydrochloride
- Generic name (nonproprietary)
- memantine
- Active ingredients
- Memantine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090041
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-169_e3662d8d-b6da-40c6-84d4-1b5d467b1eb8SPL ID e3662d8d-b6da-40c6-84d4-1b5d467b1eb8SPL set ID f73e0df0-4af4-42f1-bde6-3cccb47ca378RxCUI 996561, 996571UNII JY0WD0UA60UPC 0365162169065
- Pharmacologic class
- 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
N465162016906followed by a unit qualifier and the quantityPackage 65162-0169-06. 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 hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090041
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 |
|---|---|---|---|---|
| Memantine hydrochloridememantine | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-169 |
| Memantine hydrochloridememantine | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-173 |
| memantine hydrochloridememantine | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-173 |