Memantine Hydrochloride NDC 71335-1908

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-1908Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-1908Add 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
71335-1908-1	71335190801	30 TABLET, FILM COATED in 1 BOTTLE (71335-1908-1)Marketed from Jul 15, 2021
71335-1908-2	71335190802	60 TABLET, FILM COATED in 1 BOTTLE (71335-1908-2)Marketed from Jul 15, 2021
71335-1908-3	71335190803	90 TABLET, FILM COATED in 1 BOTTLE (71335-1908-3)Marketed from Jul 15, 2021
71335-1908-4	71335190804	180 TABLET, FILM COATED in 1 BOTTLE (71335-1908-4)Marketed from Jul 15, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090058
Marketing start: Jul 11, 2015
Listing expires: Dec 31, 2026
Other FDA classes: NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 71335-1908_417d1056-9d1c-47c4-a065-ca8bd6397982SPL ID 417d1056-9d1c-47c4-a065-ca8bd6397982SPL set ID 2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929RxCUI 996561UNII 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

N471335190801 followed by a unit qualifier and the quantity

Package 71335-1908-01. 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 Apr 5, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090058

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

FDA NDC Directory listings under ANDA 090058
Product	Strength	Form · route	Labeler	Product NDC
Memantine Hydrochloride	Memantine hydrochloride 5 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-321
Memantine Hydrochloride	Memantine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-322