Prescription drug · ANDA
Donepezil Hydrochloride NDC 71335-2022
Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2022-1 | 7133520220171335202201 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2022-1)Marketed from Apr 3, 2024 | |
| 71335-2022-2 | 7133520220271335202202 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2022-2)Marketed from Dec 22, 2021 | |
| 71335-2022-3 | 7133520220371335202203 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2022-3)Marketed from Apr 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-2022_c311f933-2648-4bf4-9328-a8c99ee8e9d9SPL ID c311f933-2648-4bf4-9328-a8c99ee8e9d9SPL set ID aa2c22b8-2dd4-4916-bc4f-9995eab74a6eRxCUI 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
N471335202201followed by a unit qualifier and the quantityPackage 71335-2022-01. 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 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 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 71335-2022
- What is NDC 71335-2022?
- 71335-2022 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Donepezil Hydrochloride.
- What is the active ingredient?
- Donepezil hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 Hydrochloride?
- 60 other product NDCs are listed under this name. See all Donepezil Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Donepezil Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Donepezil hydrochloride | Donepezil hydrochloride 23 mg/1 | Tablet, Film coatedOral | Dr. Reddys Laboratories Limited | 55111-302 | 55111-0302-3055111-0302-90 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4392 | 70518-4392-00 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1476 | 67046-1476-03 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8711 | 68788-8711-0368788-8711-0668788-8711-09 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8208 | 68788-8208-0368788-8208-0668788-8208-09 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | DirectRx | 72189-265 | 72189-0265-90 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-031 | 72189-0031-30 |
| donepezil hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1666 | 70518-1666-0070518-1666-01 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-019 | 71209-0019-0171209-0019-0471209-0019-11 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cadila Pharmaceuticals Limited | 71209-020 | 71209-0020-0171209-0020-0471209-0020-11 |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7951 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8313 |
| 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 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6329 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0416 |