Prescription drug · ANDA
Memantine NDC 0615-8192
Memantine hydrochloride 5 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8192-39 | 00615819239 | 30 TABLET in 1 BLISTER PACK (0615-8192-39)Marketed from Apr 6, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- memantine
- Active ingredients
- Memantine hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090048
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0615-8192_b4ebdb70-3b13-4041-a691-3adb3dc6687bSPL ID b4ebdb70-3b13-4041-a691-3adb3dc6687bSPL set ID a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67RxCUI 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
N400615819239followed by a unit qualifier and the quantityPackage 00615-8192-39. 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 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090048
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 | Cardinal Health 107, LLC | 55154-4151 |
| Memantine | Memantine hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-173 |
| Memantine | Memantine hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-184 |
| Memantine | Memantine hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-118 |
| Memantine | Memantine hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-119 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6505 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6506 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Limited | 55111-597 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Limited | 55111-596 |
| Memantine | Memantine hydrochloride 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8319 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7637 |