Prescription drug · ANDA
Memantine Hydrochloride NDC 0615-8662
Memantine hydrochloride 28 mg/1 · Capsule, Extended release · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8662-39 | 00615866239 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8662-39)Marketed from Aug 26, 2026 |
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 Hydrochloride
- Generic name (nonproprietary)
- memantine hydrochloride
- Active ingredients
- Memantine hydrochloride — 28 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214651
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0615-8662_c1bd01fa-4fa1-4867-b167-ab79d851f30fSPL ID c1bd01fa-4fa1-4867-b167-ab79d851f30fSPL set ID 007d4cb9-3fa9-40f3-b5ca-4083eccd6038RxCUI 996609UNII 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
N400615866239followed by a unit qualifier and the quantityPackage 00615-8662-39. 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 extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is a 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 214651
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 21 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-406 |
| Memantine Hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-404 |
| Memantine Hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-405 |
| Memantine Hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Aurobindo Pharma Limited | 59651-407 |
| Memantine Hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-408 |