Prescription drug · ANDA
Fesoterodine fumarate NDC 43598-247
Fesoterodine fumarate 4 mg/1 · Tablet, Extended release · Oral · Dr.Reddy's Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-247-30 | 43598024730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-247-30)Marketed from Jun 10, 2022 | |
| 43598-247-90 | 43598024790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-247-90)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 — 4 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 43598-247_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
N443598024730followed by a unit qualifier and the quantityPackage 43598-0247-30. 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.
Other NDCs under ANDA 204975
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, Extended releaseOral | Dr.Reddy's Laboratories Inc., | 43598-248 |
| Fesoterodine fumarate | Fesoterodine fumarate 4 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-661 |
| Fesoterodine fumarate | Fesoterodine fumarate 8 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-662 |