Prescription drug · ANDA
Memantine Hydrochloride NDC 70436-054
Memantine hydrochloride 7 mg/1 · Capsule, Extended release · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-054-04 | 70436005404 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-054-04)Marketed from Nov 15, 2021 |
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 — 7 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211100
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70436-054_5003d132-8e5e-799f-e063-6394a90a5029SPL ID 5003d132-8e5e-799f-e063-6394a90a5029SPL set ID a74050c4-5a37-4fa1-85d9-85831525cfebRxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60UPC 0370436054046, 0370436057047, 0370436056040, 0370436055067, 0370436057061, 0370436055043
- 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
N470436005404followed by a unit qualifier and the quantityPackage 70436-0054-04. 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 Capsules 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.
Other NDCs under ANDA 211100
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 21 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-056 |
| Memantine Hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-055 |
| Memantine Hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-057 |