Memantine Hydrochloride NDC 69680-162

NDC codes

FDA NDC Directory

Product NDC (as listed)69680-162Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69680-0162Add 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	Copy
69680-162-30	69680016230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-162-30)Marketed from Dec 15, 2023

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 — 14 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Vitruvias Therapeutics, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213985
Marketing start: Dec 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 69680-162_64b8e27d-8127-4df2-a089-dbcd873c4e5eSPL ID 64b8e27d-8127-4df2-a089-dbcd873c4e5eSPL set ID 0c7fd6ab-2ce5-4110-b6e6-9103c8da0765RxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60UPC 0369680163307, 0369680162300, 0369680164304, 0369680161303
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

N469680016230 followed by a unit qualifier and the quantity

Package 69680-0162-30. 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 Feb 16, 2024.

Indications (excerpt from the label)

Memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Memantine hydrochloride extended-release capsules is 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 213985

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

FDA NDC Directory listings under ANDA 213985
Product	Strength	Form · route	Labeler	Product NDC
Memantine Hydrochloride	Memantine hydrochloride 21 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-163
Memantine Hydrochloride	Memantine hydrochloride 7 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-161
Memantine Hydrochloride	Memantine hydrochloride 28 mg/1	Capsule, Extended releaseOral	Vitruvias Therapeutics, Inc.	69680-164