Prescription drug · ANDA
Memantine Hydrochloride NDC 50090-4434
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4434-0 | 50090443400 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-4434-0)Marketed from Jul 22, 2019 | |
| 50090-4434-1 | 50090443401 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-4434-1)Marketed from Oct 20, 2022 | |
| 50090-4434-2 | 50090443402 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-4434-2)Marketed from Oct 20, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200022
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-4434_94798fba-7e49-4943-b971-0362b5155219SPL ID 94798fba-7e49-4943-b971-0362b5155219SPL set ID ca619439-f4ca-43f1-9261-9aa2b6dc7450RxCUI 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
N450090443400followed by a unit qualifier and the quantityPackage 50090-4434-00. 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 an N-methyl-D-asparate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 ) Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200022
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 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5926 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-588 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-587 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-171 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-172 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-979 |