Prescription drug · ANDA
Donepezil Hydrochloride NDC 72189-031
Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-031-30 | 72189003130 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-031-30)Marketed from Oct 1, 2019 |
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
- Direct_Rx
- 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 72189-031_2c4e974d-41bb-49ca-e063-6394a90ae3a0SPL ID 2c4e974d-41bb-49ca-e063-6394a90ae3a0SPL set ID 93dddf28-094b-dd8c-e053-2995a90a63e9RxCUI 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
N472189003130followed by a unit qualifier and the quantityPackage 72189-0031-30. 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.
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 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 5 mg/1 | Tablet, Film coatedOral | Solco Healthcare US, LLC | 43547-275 |
| 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 |