Prescription drug · ANDA
Memantine and Donepezil Hydrochlorides Extended-release (Memantine and donepezil) NDC 69238-1553
Memantine hydrochloride 21 mg/1; Donepezil hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1553-3 | 6923815530369238155303 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-3)Marketed from Feb 1, 2017 | |
| 69238-1553-9 | 6923815530969238155309 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-9)Marketed from Feb 1, 2017 |
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 and Donepezil Hydrochlorides Extended-release
- Generic name (nonproprietary)
- memantine and donepezil
- Active ingredients
- Memantine hydrochloride — 21 mg/1Donepezil hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208328
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69238-1553_acd577e1-312c-4d5a-85b5-bc50ef9de545SPL ID acd577e1-312c-4d5a-85b5-bc50ef9de545SPL set ID 2335950c-be3b-4248-ad04-e9763aee47d2RxCUI 1599803, 1599805, 1805420, 1805425UNII 3O2T2PJ89D, JY0WD0UA60UPC 0369238124897, 0369238155396, 0369238124798, 0369238155297
- 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
N469238155303followed by a unit qualifier and the quantityPackage 69238-1553-03. 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 .
Indications (excerpt from the label)
Memantine and donepezil hydrochlorides extended-release capsules are 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 are 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 69238-1553
- What is NDC 69238-1553?
- 69238-1553 is the product NDC for Memantine and Donepezil Hydrochlorides Extended-release, Memantine hydrochloride 21 mg/1; Donepezil hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Memantine and Donepezil Hydrochlorides Extended-release (Memantine and Donepezil).
- What is the active ingredient?
- Memantine hydrochloride, Donepezil hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 and Donepezil Hydrochlorides Extended-release?
- 4 other product NDCs are listed under this name. See all Memantine and Donepezil Hydrochlorides Extended-release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Memantine and Donepezil Hydrochlorides Extended-release 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 and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-004 | 73190-0004-30 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1247 | 69238-1247-0369238-1247-09 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1248 | 69238-1248-0369238-1248-09 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 7 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1552 | 69238-1552-0369238-1552-09 |
Other NDCs under ANDA 208328
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 and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1247 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 14 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1248 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 7 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1552 |
| Memantine and Donepezil Hydrochlorides Extended-releasememantine and donepezil | Memantine hydrochloride 28 mg/1; Donepezil hydrochloride 10 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-004 |