Prescription drug · ANDA
Memantine hydrochloride (Memantine) NDC 53746-169
Memantine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-169-10 | 5374601691053746016910 | 1000 TABLET, FILM COATED in 1 BOTTLE (53746-169-10)Marketed from Apr 30, 2015 | |
| 53746-169-30 | 5374601693053746016930 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-169-30)Marketed from Apr 30, 2015 | |
| 53746-169-60 | 5374601696053746016960 | 60 TABLET, FILM COATED in 1 BOTTLE (53746-169-60)Marketed from Apr 30, 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
- Active ingredients
- Memantine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090041
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 53746-169_cf08de43-a887-40f3-a074-57ecc8d3093aSPL ID cf08de43-a887-40f3-a074-57ecc8d3093aSPL set ID 054069b5-7aac-4106-821f-ebf7fd531b4fRxCUI 996561, 996571UNII JY0WD0UA60UPC 0353746169105, 0353746169303, 0353746173300, 0353746173102
- 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
N453746016910followed by a unit qualifier and the quantityPackage 53746-0169-10. 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 .
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 tablets are 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.
About NDC 53746-169
- What is NDC 53746-169?
- 53746-169 is the product NDC for Memantine hydrochloride (memantine), Memantine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Memantine hydrochloride (Memantine).
- What is the active ingredient?
- Memantine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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 28 mg/1 | Capsule, Extended releaseOral | Macleods Pharmaceuticals Limited | 33342-222 | 33342-0222-0733342-0222-12 |
| 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 |
Other NDCs under ANDA 090041
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 hydrochloridememantine | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-173 |
| memantine hydrochloridememantine | Memantine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-169 |
| memantine hydrochloridememantine | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-173 |