Memantine Hydrochloride NDC 65162-785

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-785Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0785Add 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
65162-785-03	65162078503	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-03)Marketed from Dec 22, 2017
65162-785-09	65162078509	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-09)Marketed from Dec 22, 2017
65162-785-50	65162078550	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-50)Marketed from Dec 22, 2017

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 — 28 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205825
Marketing start: Dec 22, 2017
Listing expires: Dec 31, 2026
Other FDA classes: NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-785_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5SPL ID fb7782a5-2357-4a21-86a6-0eeaa7cdcea5SPL set ID f2b7538d-8ca1-4ac7-a172-d268e2fa9a52RxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60UPC 0365162784091, 0365162783094, 0365162785098, 0365162782097
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

N465162078503 followed by a unit qualifier and the quantity

Package 65162-0785-03. 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 Apr 29, 2025.

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 extended-release capsules are 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205825

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

FDA NDC Directory listings under ANDA 205825
Product	Strength	Form · route	Labeler	Product NDC
Memantine Hydrochloride	Memantine hydrochloride 7 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-782
Memantine Hydrochloride	Memantine hydrochloride 14 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-783
Memantine Hydrochloride	Memantine hydrochloride 21 mg/1	Capsule, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-784