Prescription drug · ANDA
Donepezil Hydrochloride NDC 55154-7882
Donepezil hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-7882-0 | 55154788200 | 10 BLISTER PACK in 1 BAG (55154-7882-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 28, 2011 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090686
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 55154-7882_db6ae9ea-0cf0-4e02-8131-9c457c71ef53SPL ID db6ae9ea-0cf0-4e02-8131-9c457c71ef53SPL set ID c942a4c9-dbe5-4131-bb6c-aa2d31b387e7RxCUI 997223, 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
N455154788200followed by a unit qualifier and the quantityPackage 55154-7882-00. 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 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 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090686
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 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6477 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6478 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-102 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-103 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7883 |