Prescription drug · ANDA
Donepezil (Donepezil hydrochloride) NDC 82009-120
Donepezil hydrochloride 10 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-120-05 | 8200901200582009012005 | 500 TABLET in 1 BOTTLE (82009-120-05)Marketed from Jul 19, 2023 |
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
- Quallent Pharmaceuticals Health LLCNDC labeler code 82009
- 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 82009-120_4533e92e-9af5-cce3-e063-6294a90ac926SPL ID 4533e92e-9af5-cce3-e063-6294a90ac926SPL set ID c7e1f642-1bdc-4ed6-9b9e-c1af40b926cdRxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0382009119052, 0382009120058
- 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
N482009012005followed by a unit qualifier and the quantityPackage 82009-0120-05. 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.
About NDC 82009-120
- What is NDC 82009-120?
- 82009-120 is the product NDC for Donepezil (donepezil hydrochloride), Donepezil hydrochloride 10 mg/1 tablet, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Donepezil (Donepezil hydrochloride).
- What is the active ingredient?
- Donepezil hydrochloride.
- Who is the labeler?
- Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Donepezil?
- 7 other product NDCs are listed under this name. See all Donepezil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Donepezil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4380 | 70518-4380-00 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-119 | 82009-0119-05 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-292 | 60687-0292-01 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-303 | 60687-0303-01 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-737 | 31722-0737-0131722-0737-0531722-0737-30+2 more |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-738 | 31722-0738-0131722-0738-0531722-0738-30+2 more |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2627 | 50090-2627-00 |
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 | Camber Pharmaceuticals, Inc. | 31722-737 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-738 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-2627 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-292 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-303 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4380 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-119 |