Prescription drug · ANDA
Memantine hydrochloride NDC 70771-1322
Memantine hydrochloride 14 mg/1 · Capsule, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1322-3 | 70771132203 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1322-3)Marketed from Apr 8, 2018 | |
| 70771-1322-4 | 70771132204 | 10 BLISTER PACK in 1 CARTON (70771-1322-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1322-2)Marketed from Apr 8, 2018 | |
| 70771-1322-9 | 70771132209 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1322-9)Marketed from Apr 8, 2018 |
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 — 14 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203293
- Marketing start
- Listing expires
- Other FDA classes
- NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1322_900483ef-de89-464c-a324-8bfaa8f137a6SPL ID 900483ef-de89-464c-a324-8bfaa8f137a6SPL set ID ec825bef-2313-45c2-8858-b43197680155RxCUI 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
N470771132203followed by a unit qualifier and the quantityPackage 70771-1322-03. 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 .
Other NDCs under ANDA 203293
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 | Zydus Pharmaceuticals USA Inc. | 68382-546 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-549 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-547 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-548 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1323 |
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1321 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1324 |