Prescription drug · ANDA
Memantine Hydrochloride NDC 50090-6400
Memantine hydrochloride 10 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6400-0 | 50090640000 | 90 TABLET in 1 BOTTLE (50090-6400-0)Marketed from Mar 16, 2023 | |
| 50090-6400-1 | 50090640001 | 60 TABLET in 1 BOTTLE (50090-6400-1)Marketed from Mar 16, 2023 | |
| 50090-6400-2 | 50090640002 | 180 TABLET in 1 BOTTLE (50090-6400-2)Marketed from Mar 16, 2023 |
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
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206528
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 50090-6400_0f1a6f0c-50ec-4e4b-a804-5385a2fd2e40SPL ID 0f1a6f0c-50ec-4e4b-a804-5385a2fd2e40SPL set ID d1c2ec99-7183-46e3-a96e-4f23e20b8b06RxCUI 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
N450090640000followed by a unit qualifier and the quantityPackage 50090-6400-00. 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 USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride USP 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 ANDA 206528
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 | Bryant Ranch Prepack | 71335-1899 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-885 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8647 |
| Memantine HCL | Memantine hydrochloride 10 mg/1 | TabletOral | Direct_Rx | 72189-538 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-070 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-071 |