Prescription drug · ANDA
Fesoterodine Fumarate NDC 31722-033
Fesoterodine fumarate 4 mg/1 · Tablet, Film coated, Extended release · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-033-30 | 31722003330 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30)Marketed from Jan 9, 2024 | |
| 31722-033-90 | 31722003390 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90)Marketed from Jan 9, 2024 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204792
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-033_2f836bf8-7034-db2e-e063-6394a90a3a3eSPL ID 2f836bf8-7034-db2e-e063-6394a90a3a3eSPL set ID dc532c6c-ff0d-488a-8a92-b1b0f37c944eRxCUI 810071, 810077UNII EOS72165S7UPC 0331722033305, 0331722034302
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
N431722003330followed by a unit qualifier and the quantityPackage 31722-0033-30. 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 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 is indicated for the treatment of neurogenic detrusor overactivity (N…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204792
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 8 mg/1 | Tablet, Film coated, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-034 |
| Fesoterodine Fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-414 |
| Fesoterodine Fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 72603-413 |