Prescription drug · ANDA
Donepezil Hydrochloride NDC 0615-8313
Donepezil hydrochloride 10 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8313-05 | 00615831305 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-05)Marketed from Aug 21, 2019 | |
| 0615-8313-28 | 00615831328 | 28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-28)Marketed from Jan 6, 2025 | |
| 0615-8313-30 | 00615831330 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8313-30) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 19, 2019 | |
| 0615-8313-39 | 00615831339 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8313-39)Marketed from Aug 21, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 201146
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8313_d950c91f-51cd-4f96-8562-971798db2edfSPL ID d950c91f-51cd-4f96-8562-971798db2edfSPL set ID 7620f41a-3eef-453b-a564-ea3c85374de2RxCUI 997223UNII 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
N400615831305followed by a unit qualifier and the quantityPackage 00615-8313-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 201146
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 | A-S Medication Solutions | 50090-6329 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2022 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7951 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0416 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-027 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-028 |