Prescription drug · ANDA
donepezil hydrochloride NDC 43547-275
Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-275-03 | 43547027503 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-03)Marketed from Nov 1, 2011 | |
| 43547-275-09 | 43547027509 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-09)Marketed from Nov 1, 2011 | |
| 43547-275-11 | 43547027511 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-275-11)Marketed from Nov 1, 2011 |
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)
- donepezil hydrochloride
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200292
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-275_dcfd9a94-e1bc-4b53-ae6f-0200ee714917SPL ID dcfd9a94-e1bc-4b53-ae6f-0200ee714917SPL set ID 042a59ea-131a-4806-b0f4-2f791d4414e2RxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0343547276034, 0343547275037
- Pharmacologic class
- Cholinesterase Inhibitor
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
N443547027503followed by a unit qualifier and the quantityPackage 43547-0275-03. 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)
Donepezil hydrochloride is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease. Donepezil hydrochloride is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200292
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 |
|---|---|---|---|---|
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1666 |
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-304 |
| donepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-305 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-031 |
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0900 |
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-879 |
| donepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-878 |
| donepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3537 |
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-276 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-265 |