Memantine Hydrochloride NDC 46708-451

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-451Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0451Add 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
46708-451-10	46708045110	100 TABLET, COATED in 1 CARTON (46708-451-10)Marketed from Oct 13, 2015
46708-451-20	46708045120	20 TABLET, COATED in 1 BOTTLE (46708-451-20)Marketed from Oct 13, 2015
46708-451-30	46708045130	30 TABLET, COATED in 1 BOTTLE (46708-451-30)Marketed from Oct 13, 2015
46708-451-31	46708045131	100 TABLET, COATED in 1 BOTTLE (46708-451-31)Marketed from Oct 13, 2015
46708-451-42	46708045142	3000 TABLET, COATED in 1 BOTTLE (46708-451-42)Marketed from Oct 13, 2015
46708-451-60	46708045160	60 TABLET, COATED in 1 BOTTLE (46708-451-60)Marketed from Oct 13, 2015
46708-451-91	46708045191	1000 TABLET, COATED in 1 BOTTLE (46708-451-91)Marketed from Oct 13, 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 hydrochloride
Active ingredients: Memantine hydrochloride — 5 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200891
Marketing start: Oct 13, 2015
Listing expires: Dec 31, 2026
Other FDA classes: NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 46708-451_3d66d5be-d570-4041-82bf-6b6f4eef9ed8SPL ID 3d66d5be-d570-4041-82bf-6b6f4eef9ed8SPL set ID b86c0f6e-480b-40e7-aa4d-21bd0659101dRxCUI 996561, 996571UNII JY0WD0UA60UPC 0346708452605, 0346708451608
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

N446708045110 followed by a unit qualifier and the quantity

Package 46708-0451-10. 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 Jan 30, 2023.

Indications (excerpt from the label)

Memantine hydrochloride is indiacted 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200891

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

FDA NDC Directory listings under ANDA 200891
Product	Strength	Form · route	Labeler	Product NDC
Memantine Hydrochloride	Memantine hydrochloride 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Limited	46708-452
Memantine Hydrochloride	Memantine hydrochloride 5 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-075
Memantine Hydrochloride	Memantine hydrochloride 10 mg/1	Tablet, CoatedOral	Alembic Pharmaceuticals Inc.	62332-076