Prescription drug · ANDA
Donepezil (donepezil hydrochloride) NDC 31722-738
Donepezil hydrochloride 10 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-738-01 | 31722073801 | 100 TABLET in 1 BOTTLE (31722-738-01)Marketed from Feb 2, 2015 | |
| 31722-738-05 | 31722073805 | 500 TABLET in 1 BOTTLE (31722-738-05)Marketed from Feb 2, 2015 | |
| 31722-738-30 | 31722073830 | 30 TABLET in 1 BOTTLE (31722-738-30)Marketed from Feb 2, 2015 | |
| 31722-738-31 | 31722073831 | 100 TABLET in 1 BLISTER PACK (31722-738-31)Marketed from Feb 2, 2015 | |
| 31722-738-90 | 31722073890 | 90 TABLET in 1 BOTTLE (31722-738-90)Marketed from Feb 2, 2015 |
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
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203034
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-738_2b1d0795-adc8-39e4-e063-6294a90a91cbSPL ID 2b1d0795-adc8-39e4-e063-6294a90a91cbSPL set ID 11ac01f4-d26e-47b2-9660-d514ab097fdbRxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0331722737302, 0331722738309
- 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
N431722073801followed by a unit qualifier and the quantityPackage 31722-0738-01. 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 tablet, 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 203034
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 |
|---|---|---|---|---|
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-119 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-120 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-303 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-292 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4380 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2627 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-737 |