Prescription drug · ANDA
Memantine HCL NDC 72189-538
Memantine hydrochloride 10 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-538-60 | 72189053860 | 60 TABLET in 1 BOTTLE (72189-538-60)Marketed from Feb 29, 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 HCL
- Generic name (nonproprietary)
- memantine hcl
- Active ingredients
- Memantine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct_Rx
- 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 72189-538_1289db0e-517a-d157-e063-6294a90ab758SPL ID 1289db0e-517a-d157-e063-6294a90ab758SPL set ID 1289db0e-5179-d157-e063-6294a90ab758RxCUI 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
N472189053860followed by a unit qualifier and the quantityPackage 72189-0538-60. 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.
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 | A-S Medication Solutions | 50090-6400 |
| 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 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 |