Prescription drug · ANDA
Memantine Hydrochloride NDC 50268-588
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-588-13 | 50268058813 | 30 BLISTER PACK in 1 BOX (50268-588-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-588-11)Marketed from Feb 20, 2024 |
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, Film coated
- Route
- Oral
- Labeler
- AvPAK
- 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 50268-588_47e7cea9-cd6c-40d4-e063-6294a90a9e8aSPL ID 47e7cea9-cd6c-40d4-e063-6294a90a9e8aSPL set ID 11d27c75-fdc0-f9da-e063-6394a90ac6b0RxCUI 996561, 996571UNII 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
N450268058813followed by a unit qualifier and the quantityPackage 50268-0588-13. 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 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4434 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5926 |
| 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 |