Memantine hydrochloride (memantine) NDC 53746-169

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-169Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0169Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
53746-169-10	53746016910	1000 TABLET, FILM COATED in 1 BOTTLE (53746-169-10)Marketed from Apr 30, 2015
53746-169-30	53746016930	30 TABLET, FILM COATED in 1 BOTTLE (53746-169-30)Marketed from Apr 30, 2015
53746-169-60	53746016960	60 TABLET, FILM COATED in 1 BOTTLE (53746-169-60)Marketed from Apr 30, 2015

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
Active ingredients: Memantine hydrochloride — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090041
Marketing start: Apr 30, 2015
Listing expires: Dec 31, 2026
Other FDA classes: NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 53746-169_cf08de43-a887-40f3-a074-57ecc8d3093aSPL ID cf08de43-a887-40f3-a074-57ecc8d3093aSPL set ID 054069b5-7aac-4106-821f-ebf7fd531b4fRxCUI 996561, 996571UNII JY0WD0UA60UPC 0353746169105, 0353746169303, 0353746173300, 0353746173102
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

N453746016910 followed by a unit qualifier and the quantity

Package 53746-0169-10. 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 Aug 17, 2023.

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 tablets are 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090041

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090041
Product	Strength	Form · route	Labeler	Product NDC
Memantine hydrochloridememantine	Memantine hydrochloride 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals of New York LLC	53746-173
memantine hydrochloridememantine	Memantine hydrochloride 10 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-169
memantine hydrochloridememantine	Memantine hydrochloride 5 mg/1	Tablet, Film coatedOral	Amneal Pharmaceuticals LLC	65162-173