Prescription drug · ANDA
Memantine NDC 0615-8319
Memantine hydrochloride 10 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8319-05 | 0061583190500615831905 | 15 TABLET in 1 BLISTER PACK (0615-8319-05)Marketed from Sep 3, 2019 | |
| 0615-8319-39 | 0061583193900615831939 | 30 TABLET in 1 BLISTER PACK (0615-8319-39)Marketed from Sep 3, 2019 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- 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 0615-8319_f52d94bf-167f-48f1-bc69-37bc8acde5dfSPL ID f52d94bf-167f-48f1-bc69-37bc8acde5dfSPL set ID 5c8a168d-aef5-4ac7-b8c1-3812a8c228abRxCUI 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
N400615831905followed by a unit qualifier and the quantityPackage 00615-8319-05. 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. (1)
Excerpt only. Read the full label for complete information.
About NDC 0615-8319
- What is NDC 0615-8319?
- 0615-8319 is the product NDC for Memantine, Memantine hydrochloride 10 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Memantine.
- What is the active ingredient?
- Memantine hydrochloride.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Memantine?
- 8 other product NDCs are listed under this name. See all Memantine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Memantine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Memantine | Memantine hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-118 | 72603-0118-01 |
| Memantine | Memantine hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-119 | 72603-0119-0172603-0119-02 |
| memantine | Memantine hydrochloride 5 mg/1 | TabletOral | Chartwell RX, LLC | 62135-895 | 62135-0895-60 |
| memantine | Memantine hydrochloride 10 mg/1 | TabletOral | Chartwell RX, LLC | 62135-896 | 62135-0896-60 |
| Memantinememantine hydrochloride | Memantine hydrochloride 2 mg/mL | SolutionOral | Apotex Corp. | 60505-6162 | 60505-6162-05 |
| Memantine | Memantine hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-184 | 60687-0184-57 |
| Memantine | Memantine hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-173 | 60687-0173-57 |
| Memantine | Memantine hydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8192 | 00615-8192-39 |
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 | Memantine hydrochloride 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8192 |
| 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 5 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Limited | 55111-596 |
| 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 | Cardinal Health 107, LLC | 55154-4151 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7637 |