Fesoterodine Fumarate NDC 65862-767

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-767Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0767Add 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
65862-767-30	65862076730	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-767-30)Marketed from Jun 17, 2022

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, Film coated, Extended release
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205007
Marketing start: Jun 17, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 65862-767_33d91059-f2d5-482f-a47f-b1dccb7c5b22SPL ID 33d91059-f2d5-482f-a47f-b1dccb7c5b22SPL set ID dc8f6158-3c2b-4ec0-a951-e04468b83bb1RxCUI 810071, 810077UNII EOS72165S7UPC 0365862766304, 0365862767301

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

N465862076730 followed by a unit qualifier and the quantity

Package 65862-0767-30. 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 Dec 2, 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 ) Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2 ) 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. 1.2 Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (ND…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205007

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

FDA NDC Directory listings under ANDA 205007
Product	Strength	Form · route	Labeler	Product NDC
Fesoterodine Fumarate	Fesoterodine fumarate 4 mg/1	Tablet, Film coated, Extended releaseOral	Aurobindo Pharma Limited	65862-766