Prescription drug · ANDA
Memantine Hydrochloride NDC 63629-2514
Memantine hydrochloride 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2514-1 | 63629251401 | 60 TABLET in 1 BOTTLE (63629-2514-1)Marketed from May 18, 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090961
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63629-2514_16652984-6db6-4780-9fa8-8faf436c404cSPL ID 16652984-6db6-4780-9fa8-8faf436c404cSPL set ID fac8c59b-5bf5-478e-8223-a5ecaa400625RxCUI 996571UNII 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
N463629251401followed by a unit qualifier and the quantityPackage 63629-2514-01. 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 .
Indications (excerpt from the label)
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 ) Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090961
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 10 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1120 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1119 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Coupler LLC | 67046-1471 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3338 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2003 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2004 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1603 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-911 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | DirectRx | 72189-294 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2013 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2512 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6291 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2511 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1732 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2513 |
| Memantine Hydrochloride | Memantine hydrochloride 10 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-004 |
| Memantine Hydrochloride | Memantine hydrochloride 5 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-003 |