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 | 1392505401213925054012 | 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 PharmaceuticalsNDC labeler code 13925
- 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.
About NDC 13925-540
- What is NDC 13925-540?
- 13925-540 is the product NDC for Memantine Hydrochloride (memantine hydrochloride oral), Memantine hydrochloride 2 mg/mL solution, listed with the FDA by Seton Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Memantine Hydrochloride (Memantine Hydrochloride Oral).
- What is the active ingredient?
- Memantine hydrochloride.
- Who is the labeler?
- Seton Pharmaceuticals, NDC labeler code 13925. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Memantine Hydrochloride?
- 111 other product NDCs are listed under this name. See all Memantine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Memantine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-219 | 33342-0219-0733342-0219-12 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-220 | 33342-0220-0733342-0220-12 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-221 | 33342-0221-0733342-0221-12 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-222 | 33342-0222-0733342-0222-12 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-192 | 61442-0192-0561442-0192-60 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-193 | 61442-0193-0561442-0193-60 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-852 | 16571-0852-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-853 | 16571-0853-0316571-0853-09 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-854 | 16571-0854-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-855 | 16571-0855-0316571-0855-09 |