Prescription drug · ANDA
Memantine Hydrochloride NDC 59651-406
Memantine hydrochloride 21 mg/1 · Capsule, Extended release · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-406-30 | 59651040630 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-406-30)Marketed from Aug 9, 2021 | |
| 59651-406-90 | 59651040690 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-406-90)Marketed from Aug 9, 2021 |
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 — 21 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- 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 59651-406_7a208302-90f3-45d0-94fc-9fb38591c543SPL ID 7a208302-90f3-45d0-94fc-9fb38591c543SPL set ID 2b2dcd54-47e0-494b-85d2-c28c3adbe737RxCUI 996594, 996603, 996609, 996615, 996624UNII JY0WD0UA60UPC 0359651406304, 0359651404300
- 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
N459651040630followed by a unit qualifier and the quantityPackage 59651-0406-30. 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 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 |
| Memantine Hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8662 |