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| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-222-07 | 3334202220733342022207 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07)Marketed from Aug 28, 2025 | |
| 33342-222-12 | 3334202221233342022212 | 10 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
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- 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
N433342022207followed by a unit qualifier and the quantityPackage 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.
About NDC 33342-222
- What is NDC 33342-222?
- 33342-222 is the product NDC for Memantine hydrochloride, Memantine hydrochloride 28 mg/1 capsule, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Memantine hydrochloride.
- What is the active ingredient?
- Memantine hydrochloride.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Memantine hydrochloride?
- 111 other product NDCs are listed under this name. See all Memantine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Memantine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-219 | 33342-0219-0733342-0219-12 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-220 | 33342-0220-0733342-0220-12 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-221 | 33342-0221-0733342-0221-12 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-192 | 61442-0192-0561442-0192-60 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Carlsbad Technology, Inc. | 61442-193 | 61442-0193-0561442-0193-60 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-852 | 16571-0852-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-853 | 16571-0853-0316571-0853-09 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-854 | 16571-0854-03 |
| Memantine Hydrochloridememantine | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Rising Pharma Holdings, Inc. | 16571-855 | 16571-0855-0316571-0855-09 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-1471 | 67046-1471-03 |
Other NDCs under ANDA 206310
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-219 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-220 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-221 |