Prescription drug · ANDA
Solifenacin Succinate NDC 71205-561
Solifenacin succinate 5 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-561-30 | 71205056130 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-561-30)Marketed from May 7, 2021 | |
| 71205-561-60 | 71205056160 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-561-60)Marketed from May 7, 2021 | |
| 71205-561-90 | 71205056190 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-561-90)Marketed from May 7, 2021 |
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)
- Solifenacin Succinate
- Generic name (nonproprietary)
- solifenacin succinate
- Active ingredients
- Solifenacin succinate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210224
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 71205-561_a3a77fb3-af3f-4c6f-be7e-8ce349d2a2ccSPL ID a3a77fb3-af3f-4c6f-be7e-8ce349d2a2ccSPL set ID c67107f4-348b-4a23-a67c-26fd8241ebd6RxCUI 477367UNII KKA5DLD701UPC 0371205561307
- 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
N471205056130followed by a unit qualifier and the quantityPackage 71205-0561-30. 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)
Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210224
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 |
|---|---|---|---|---|
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2985 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1729 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8867 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8868 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8869 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8870 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1848 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1849 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-527 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-528 |