Prescription drug · ANDA
memantine hydrochloride and donepezil hydrochloride NDC 69680-185
Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Vitruvias Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69680-185-30 | 6968001853069680018530 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-185-30)Marketed from Jul 16, 2025 |
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 and donepezil hydrochloride
- Generic name (nonproprietary)
- memantine hydrochloride and donepezil hydrochloride
- Active ingredients
- Memantine hydrochloride — 28 mg/1Donepezil hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Vitruvias Therapeutics, Inc.NDC labeler code 69680
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216901
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69680-185_ffe5cf41-299a-49e5-a9b8-c9048c4861faSPL ID ffe5cf41-299a-49e5-a9b8-c9048c4861faSPL set ID c888a2b2-92c6-46ae-99ea-21de616208b6RxCUI 1599803, 1599805UNII 3O2T2PJ89D, JY0WD0UA60UPC 0369680183305, 0369680185309
- 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
N469680018530followed by a unit qualifier and the quantityPackage 69680-0185-30. 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)
Memantine and donepezil hydrochlorides extended-release capsules 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. Memantine and donepezil hydrochlorides extended-release capsules 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 69680-185
- What is NDC 69680-185?
- 69680-185 is the product NDC for memantine hydrochloride and donepezil hydrochloride, Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Vitruvias Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- memantine hydrochloride and donepezil hydrochloride.
- What is the active ingredient?
- Memantine hydrochloride, Donepezil hydrochloride.
- Who is the labeler?
- Vitruvias Therapeutics, Inc., NDC labeler code 69680. 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 and donepezil hydrochloride?
- 1 other product NDC are listed under this name. See all memantine hydrochloride and donepezil 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 and donepezil 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 and donepezil hydrochloride | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-183 | 69680-0183-30 |
Other NDCs under ANDA 216901
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 and donepezil hydrochloride | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Vitruvias Therapeutics, Inc. | 69680-183 |