NDC codes

FDA NDC Directory
Product NDC (as listed)43598-248Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0248Add 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 NDC11-digit (billing)PackageCopy
43598-248-304359802483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-30)Marketed from Jun 10, 2022
43598-248-904359802489090 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-90)Marketed from Jun 10, 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, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204975
Marketing start
Listing expires
Identifiers
Product ID 43598-248_fb4f7798-3094-ebec-3314-24b3aa54f927SPL ID fb4f7798-3094-ebec-3314-24b3aa54f927SPL set ID 5c5d2a97-9029-744f-c410-a4bbbe9761a8RxCUI 810071, 810077UNII EOS72165S7UPC 0343598248301, 0343598247304

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

N443598024830 followed by a unit qualifier and the quantity

Package 43598-0248-30. 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 .

Indications (excerpt from the label)

Fesoterodine fumarate extended-release 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 (NDO) in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204975

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

FDA NDC Directory listings under ANDA 204975
ProductStrengthForm · routeLabelerProduct NDC
Fesoterodine fumarateFesoterodine fumarate 4 mg/1Tablet, Extended releaseOralDr.Reddy's Laboratories Inc.,43598-247
Fesoterodine fumarateFesoterodine fumarate 4 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-661
Fesoterodine fumarateFesoterodine fumarate 8 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.51407-662

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