Prescription drug · ANDA
donepezil hydrochloride NDC 29300-249
Donepezil hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Unichem Pharmaceuticals (USA), Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 29300-249-01 | 29300024901 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-01)Marketed from Feb 28, 2018 | |
| 29300-249-10 | 29300024910 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-10)Marketed from Feb 28, 2018 | |
| 29300-249-13 | 29300024913 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-13)Marketed from Feb 28, 2018 | |
| 29300-249-19 | 29300024919 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-249-19)Marketed from Feb 28, 2018 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203656
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 29300-249_88d3f867-45f4-42fb-93f8-235c2f594760SPL ID 88d3f867-45f4-42fb-93f8-235c2f594760SPL set ID 1a8906ce-96dc-4bc8-81c1-5db67a187aacRxCUI 997220, 997223, 997226, 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
N429300024901followed by a unit qualifier and the quantityPackage 29300-0249-01. 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 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 ) 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 203656
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 | Unichem Pharmaceuticals (USA), Inc. | 29300-248 |