Prescription drug · ANDA
Memantine NDC 72603-119
Memantine hydrochloride 10 mg/1 · Tablet · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-119-01 | 72603011901 | 60 TABLET in 1 BOTTLE (72603-119-01)Marketed from Sep 13, 2022 | |
| 72603-119-02 | 72603011902 | 500 TABLET in 1 BOTTLE (72603-119-02)Marketed from Sep 13, 2022 |
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
- Generic name (nonproprietary)
- memantine
- Active ingredients
- Memantine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NorthStar RxLLC
- 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 72603-119_dd10c9a1-a7af-b51f-4317-ee2290f19a85SPL ID dd10c9a1-a7af-b51f-4317-ee2290f19a85SPL set ID 7a40ed9d-8853-b616-ff47-0c7b0fd28959RxCUI 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
N472603011901followed by a unit qualifier and the quantityPackage 72603-0119-01. 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.
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 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 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 |