Prescription drug · ANDA
Fesoterodine Fumarate NDC 65162-370
Fesoterodine fumarate 8 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-370-03 | 6516203700365162037003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-370-03)Marketed from Jan 6, 2023 | |
| 65162-370-09 | 6516203700965162037009 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-370-09)Marketed from Jan 6, 2023 |
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)
- Fesoterodine Fumarate
- Generic name (nonproprietary)
- fesoterodine fumarate
- Active ingredients
- Fesoterodine fumarate — 8 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205002
- Marketing start
- Listing expires
- Identifiers
- Product ID 65162-370_84a0cad7-6b3b-46f3-8797-c0b922026154SPL ID 84a0cad7-6b3b-46f3-8797-c0b922026154SPL set ID 1d3fdfcf-7406-4be0-90e9-b10c9257bf69RxCUI 810071, 810077UNII EOS72165S7UPC 0365162370034, 0365162369038
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
N465162037003followed by a unit qualifier and the quantityPackage 65162-0370-03. 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)
Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Excerpt only. Read the full label for complete information.
About NDC 65162-370
- What is NDC 65162-370?
- 65162-370 is the product NDC for Fesoterodine Fumarate, Fesoterodine fumarate 8 mg/1 tablet, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fesoterodine Fumarate.
- What is the active ingredient?
- Fesoterodine fumarate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fesoterodine Fumarate?
- 21 other product NDCs are listed under this name. See all Fesoterodine Fumarate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fesoterodine Fumarate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-413 | 72603-0413-01 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-414 | 72603-0414-01 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-033 | 31722-0033-3031722-0033-90 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-034 | 31722-0034-3031722-0034-90 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-175 | 46708-0175-1046708-0175-3046708-0175-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-176 | 46708-0176-1046708-0176-3046708-0176-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-175 | 62332-0175-1062332-0175-3062332-0175-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-176 | 62332-0176-1062332-0176-3062332-0176-90+1 more |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-369 | 65162-0369-0365162-0369-09 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-766 | 65862-0766-30 |
Other NDCs under ANDA 205002
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 |
|---|---|---|---|---|
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-369 |