Prescription drug · ANDA
Donepezil Hydrochloride NDC 65862-326
Donepezil hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-326-01 | 6586203260165862032601 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-326-01)Marketed from May 31, 2011 | |
| 65862-326-05 | 6586203260565862032605 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-326-05)Marketed from May 31, 2011 | |
| 65862-326-14 | 6586203261465862032614 | 10 BLISTER PACK in 1 CARTON (65862-326-14) / 14 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 31, 2011 | |
| 65862-326-30 | 6586203263065862032630 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-326-30)Marketed from May 31, 2011 | |
| 65862-326-90 | 6586203269065862032690 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-326-90)Marketed from May 31, 2011 | |
| 65862-326-99 | 6586203269965862032699 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-326-99)Marketed from May 31, 2011 |
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 Hydrochloride
- Generic name (nonproprietary)
- donepezil hydrochloride
- Active ingredients
- Donepezil hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090056
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-326_3c956648-d46c-41e2-a2d9-8560846a7a32SPL ID 3c956648-d46c-41e2-a2d9-8560846a7a32SPL set ID 3257494f-8f44-4978-b92d-bde87b2444b6RxCUI 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
N465862032601followed by a unit qualifier and the quantityPackage 65862-0326-01. 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 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 65862-326
- What is NDC 65862-326?
- 65862-326 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 6 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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 090056
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 | Rising Pharma Holdings, Inc. | 16571-778 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-779 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7365 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-9326 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1476 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8208 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4392 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2093 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2346 |