Prescription drug · ANDA
Donepezil Hydrochloride NDC 71335-2093
Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2093-1 | 71335209301 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2093-1)Marketed from Apr 3, 2024 | |
| 71335-2093-2 | 71335209302 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2093-2)Marketed from May 6, 2022 | |
| 71335-2093-3 | 71335209303 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2093-3)Marketed from Apr 3, 2024 |
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)
- Donepezil Hydrochloride
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090056
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2093_280c4887-57c3-4d43-afca-98e64de44219SPL ID 280c4887-57c3-4d43-afca-98e64de44219SPL set ID c030fd7c-da5c-457a-a825-1767bd87d04dRxCUI 997229UNII 3O2T2PJ89D
- 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
N471335209301followed by a unit qualifier and the quantityPackage 71335-2093-01. 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 tablets are 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 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 090056
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 | Bryant Ranch Prepack | 71335-2346 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1476 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7365 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-326 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-325 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8208 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-778 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-779 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9326 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4392 |