Prescription drug · ANDA
Donepezil (donepezil hydrochloride) NDC 60687-303
Donepezil hydrochloride 10 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-303-01 | 60687030301 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-303-01) / 1 TABLET in 1 BLISTER PACK (60687-303-11)Marketed from Mar 21, 2017 |
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
- American Health Packaging
- 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 60687-303_3f922a89-21fe-d605-e063-6294a90a8b8dSPL ID 3f922a89-21fe-d605-e063-6294a90a8b8dSPL set ID 12ae85f0-023c-49ca-8c4a-0a6a7585290eRxCUI 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
N460687030301followed by a unit qualifier and the quantityPackage 60687-0303-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-738 |
| Donepezildonepezil hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-737 |