Prescription drug · ANDA
Solifenacin Succinate NDC 71205-583
Solifenacin succinate 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-583-30 | 71205058330 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-583-30)Marketed from Jun 25, 2021 | |
| 71205-583-60 | 71205058360 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-583-60)Marketed from Jun 25, 2021 | |
| 71205-583-90 | 71205058390 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-583-90)Marketed from Jun 25, 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 — 10 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 209333
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 71205-583_585474af-65d8-4ed1-9793-8439d80212feSPL ID 585474af-65d8-4ed1-9793-8439d80212feSPL set ID 70fece2c-a59f-43f9-abbf-ac67500e90bbUNII KKA5DLD701UPC 0371205583309
- 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
N471205058330followed by a unit qualifier and the quantityPackage 71205-0583-30. 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 are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of adults with 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 209333
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 5 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4702 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4703 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-559 |
| Solifenacin Succinatesolifenacin succinate tablets | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Qilu Pharmaceutical Co., Ltd. | 67184-0517 |