Prescription drug · ANDA
Memantine Hydrochloride NDC 0832-1113
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1113-60 | 00832111360 | 60 TABLET, FILM COATED in 1 BOTTLE (0832-1113-60)Marketed from Jul 31, 2015 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090043
- Marketing start
- Marketing end
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0832-1113_45af280b-1724-c805-e063-6294a90a76eeSPL ID 45af280b-1724-c805-e063-6294a90a76eeSPL set ID 6e0ade9e-b721-4701-bcb7-de464e19e707RxCUI 996561, 996571UNII JY0WD0UA60UPC 0308321113608
- 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
N400832111360followed by a unit qualifier and the quantityPackage 00832-1113-60. 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 090043
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 | Upsher-Smith Laboratories, LLC | 0832-1112 |