Prescription drug · NDA
memantine hydrochloride NDC 71610-011
Memantine hydrochloride 10 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-011-18 | 71610001118 | 3000 TABLET in 1 BOTTLE (71610-011-18)Marketed from Nov 15, 2017 |
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 hydrochloride
- Active ingredients
- Memantine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021487
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdfSPL ID f384e3d8-d9fd-481c-b924-4bf98dfb5bdfSPL set ID c8f5c20b-4573-44c5-89fc-4da11b2e1fe1RxCUI 996561UNII JY0WD0UA60
- 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
N471610001118followed by a unit qualifier and the quantityPackage 71610-0011-18. 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 is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine HCl is 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 NDA 021487
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 hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-3875 |
| memantine hydrochloride | — | KitOral | Actavis Pharma, Inc. | 0591-3900 |
| memantine hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2666 |
| memantine hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2667 |
| memantine hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-3870 |