Prescription drug · NDA
Namzaric NDC 0456-1228
memantine hydrochloride and donepezil hydrochloride · Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 · Capsule · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-1228-30 | 0045612283000456122830 | 30 CAPSULE in 1 BOTTLE (0456-1228-30)Marketed from Dec 24, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Namzaric
- Generic name (nonproprietary)
- memantine hydrochloride and donepezil hydrochloride
- Active ingredients
- Memantine hydrochloride — 28 mg/1Donepezil hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206439
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0456-1228_00cae29c-d07a-484b-b279-be68f15c5e73SPL ID 00cae29c-d07a-484b-b279-be68f15c5e73SPL set ID 90fedc32-19e5-480c-afc6-f35a5cf4b9aaRxCUI 1599803, 1599805, 1602588, 1602594, 1805420, 1805422, 1805425, 1805427, 1858970, 1858971UNII 3O2T2PJ89D, JY0WD0UA60UPC 0304561221301, 0304561207305
- Pharmacologic class
- Cholinesterase Inhibitor; 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
N400456122830followed by a unit qualifier and the quantityPackage 00456-1228-30. 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)
NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. NAMZARIC is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0456-1228
- What is NDC 0456-1228?
- 0456-1228 is the product NDC for Namzaric, Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 capsule, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Namzaric (Memantine hydrochloride and donepezil hydrochloride).
- What is the active ingredient?
- Memantine hydrochloride, Donepezil hydrochloride.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Namzaric?
- 3 other product NDCs are listed under this name. See all Namzaric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Namzaric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 7 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1207 | 00456-1207-30 |
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 21 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1221 | 00456-1221-30 |
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1214 | 00456-1214-30 |
Other NDCs under NDA 206439
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 |
|---|---|---|---|---|
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 7 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1207 |
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1214 |
| Namzaricmemantine hydrochloride and donepezil hydrochloride | Memantine hydrochloride 21 mg/1; Donepezil hydrochloride 10 mg/1 | CapsuleOral | Allergan, Inc. | 0456-1221 |