Prescription drug · ANDA

Memantine hydrochloride NDC 33342-222

Memantine hydrochloride 28 mg/1 · Capsule, Extended release · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0222Add 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 NDC11-digit (billing)PackageCopy
33342-222-073334202220730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07)Marketed from Aug 28, 2025
33342-222-123334202221210 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 28, 2025

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206310
Marketing start
Listing expires
Other FDA classes
NMDA Receptor Antagonists (Mechanism)
Identifiers
Product ID 33342-222_1c695653-b7dd-40af-b5eb-a6e3ecbab14dSPL ID 1c695653-b7dd-40af-b5eb-a6e3ecbab14dSPL set ID 62e32b0b-1eb2-424d-bfd2-d27ef27d35f3RxCUI 996594, 996603, 996609, 996615UNII 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

N433342022207 followed by a unit qualifier and the quantity

Package 33342-0222-07. 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 .

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 capsule 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 206310

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

FDA NDC Directory listings under ANDA 206310
ProductStrengthForm · routeLabelerProduct NDC
Memantine hydrochlorideMemantine hydrochloride 14 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-220
Memantine hydrochlorideMemantine hydrochloride 7 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-219
Memantine hydrochlorideMemantine hydrochloride 21 mg/1Capsule, Extended releaseOralMacleods Pharmaceuticals Limited33342-221

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Memantine hydrochloride NDC 33342-222 | Med-Code