Prescription drug · ANDA
Memantine hydrochloride NDC 68382-547
Memantine hydrochloride 14 mg/1 · Capsule, Extended release · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-547-06 | 6838205470668382054706 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-547-06)Marketed from Apr 8, 2018 | |
| 68382-547-16 | 6838205471668382054716 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-547-16)Marketed from Apr 8, 2018 | |
| 68382-547-77 | 6838205477768382054777 | 10 BLISTER PACK in 1 CARTON (68382-547-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-547-30)Marketed from Apr 8, 2018 |
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 — 14 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
- 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 68382-547_079cb172-4d62-4571-98b9-5ad01706dbeeSPL ID 079cb172-4d62-4571-98b9-5ad01706dbeeSPL set ID eac265e6-6ea4-4368-acff-2efe6a8dd40aRxCUI 996594, 996603, 996609, 996615UNII JY0WD0UA60UPC 0368382548061
- 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
N468382054706followed by a unit qualifier and the quantityPackage 68382-0547-06. 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 a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. ( 1 ) Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Excerpt only. Read the full label for complete information.
About NDC 68382-547
- What is NDC 68382-547?
- 68382-547 is the product NDC for Memantine hydrochloride, Memantine hydrochloride 14 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 3 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?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 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 21 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-548 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 68382-549 |
| Memantine hydrochloride | Memantine hydrochloride 7 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1321 |
| Memantine hydrochloride | Memantine hydrochloride 14 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1322 |
| Memantine hydrochloride | Memantine hydrochloride 21 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1323 |
| Memantine hydrochloride | Memantine hydrochloride 28 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1324 |