Prescription drug · ANDA
Donepezil Hydrochloride NDC 13668-102
Donepezil hydrochloride 5 mg/1 · Tablet, Film coated · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-102-05 | 1366801020513668010205 | 500 TABLET, FILM COATED in 1 BOTTLE (13668-102-05)Marketed from May 31, 2011 | |
| 13668-102-10 | 1366801021013668010210 | 1000 TABLET, FILM COATED in 1 BOTTLE (13668-102-10)Marketed from May 31, 2011 | |
| 13668-102-30 | 1366801023013668010230 | 30 TABLET, FILM COATED in 1 BOTTLE (13668-102-30)Marketed from May 31, 2011 | |
| 13668-102-40 | 1366801024013668010240 | 4000 TABLET, FILM COATED in 1 BOTTLE (13668-102-40)Marketed from May 31, 2011 | |
| 13668-102-90 | 1366801029013668010290 | 90 TABLET, FILM COATED in 1 BOTTLE (13668-102-90)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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090686
- Marketing start
- Listing expires
- Other FDA classes
- Cholinesterase Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-102_bc153659-2091-4682-a63b-8735e1146bacSPL ID bc153659-2091-4682-a63b-8735e1146bacSPL set ID 76bf638e-dbde-418e-8977-1caf009990bcRxCUI 997223, 997229UNII 3O2T2PJ89DUPC 0313668102307, 0313668103304
- 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
N413668010205followed by a unit qualifier and the quantityPackage 13668-0102-05. 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 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 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.
Excerpt only. Read the full label for complete information.
About NDC 13668-102
- What is NDC 13668-102?
- 13668-102 is the product NDC for Donepezil Hydrochloride, Donepezil hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Torrent Pharmaceuticals Limited. It has 5 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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 090686
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 | Major Pharmaceuticals | 0904-6477 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6478 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-103 |
| Donepezil Hydrochloride | Donepezil hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7882 |
| Donepezil Hydrochloride | Donepezil hydrochloride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7883 |