Prescription drug · ANDA
Donepezil Hydrochloride NDC 63629-8483
Donepezil hydrochloride 23 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8483-1 | 63629848301 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8483-1)Marketed from May 18, 2021 |
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 — 23 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 203104
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8483_6f78fe1c-7057-41ef-bea2-4f932a842178SPL ID 6f78fe1c-7057-41ef-bea2-4f932a842178SPL set ID caebc31c-5a35-4434-b7e2-80f6405383caRxCUI 1100184UNII 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
N463629848301followed by a unit qualifier and the quantityPackage 63629-8483-01. 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 hydrochloride tablets are 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 203104
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 23 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1276 |
| Donepezil Hydrochloride | Donepezil hydrochloride 23 mg/1 | Tablet, Film coatedOral | Upsher-Smith Laboratories, LLC | 24979-004 |
| Donepezil Hydrochloride | Donepezil hydrochloride 23 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-948 |
| Donepezil Hydrochloride | Donepezil hydrochloride 23 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-320 |