Fesoterodine Fumarate NDC 65162-369

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-369Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0369Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65162-369-03	65162036903	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-03)Marketed from Jan 6, 2023
65162-369-09	65162036909	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-369-09)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 — 4 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205002
Marketing start: Jan 6, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 65162-369_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

N465162036903 followed by a unit qualifier and the quantity

Package 65162-0369-03. 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 Apr 12, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205002

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205002
Product	Strength	Form · route	Labeler	Product NDC
Fesoterodine Fumarate	Fesoterodine fumarate 8 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-370