Prescription drug · ANDA
Darifenacin NDC 72162-2570
Darifenacin hydrobromide 7.5 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2570-3 | 72162257003 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2570-3)Marketed from Nov 17, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Darifenacin
- Generic name (nonproprietary)
- darifenacin
- Active ingredients
- Darifenacin hydrobromide — 7.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205209
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 72162-2570_2a6e97d9-19e4-42aa-86e8-27bab91f059dSPL ID 2a6e97d9-19e4-42aa-86e8-27bab91f059dSPL set ID 697eba55-9e1f-4036-baed-5644c810f166RxCUI 485423UNII CR02EYQ8GV
- Pharmacologic class
- Cholinergic Muscarinic Antagonist
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
N472162257003followed by a unit qualifier and the quantityPackage 72162-2570-03. 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 .
Indications (excerpt from the label)
Darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205209
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 |
|---|---|---|---|---|
| Darifenacin | Darifenacin hydrobromide 7.5 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-202 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Torrent Pharmaceuticals Limited | 13668-203 |
| Darifenacin | Darifenacin hydrobromide 15 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2571 |