Prescription drug · ANDA
Memantine Hydrochloride (memantine hydrochloride oral) NDC 13925-540
Memantine hydrochloride 2 mg/mL · Solution · Oral · Seton Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13925-540-12 | 13925054012 | 360 mL in 1 BOTTLE (13925-540-12)Marketed from May 19, 2021 |
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 oral
- Active ingredients
- Memantine hydrochloride — 2 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Seton Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210319
- Marketing start
- Marketing end
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9SPL ID cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9SPL set ID 421f6478-09df-49d3-a7c4-52814b4aa90eRxCUI 996740UNII 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
N413925054012followed by a unit qualifier and the quantityPackage 13925-0540-12. 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)
1. INDICATIONS AND USAGE Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride 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.