Prescription drug · ANDA
Solifenacin Succinate (solifenacin succiate) NDC 35561-285
Solifenacin succinate 5 mg/1 · Tablet, Film coated · Oral · Bostal LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35561-285-00 | 35561028500 | 256410 TABLET, FILM COATED in 1 BOX (35561-285-00)Marketed from May 20, 2019 | |
| 35561-285-10 | 35561028510 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-285-10)Marketed from May 20, 2019 | |
| 35561-285-11 | 35561028511 | 90 TABLET, FILM COATED in 1 BOTTLE (35561-285-11)Marketed from May 20, 2019 | |
| 35561-285-13 | 35561028513 | 500 TABLET, FILM COATED in 1 BOTTLE (35561-285-13)Marketed from May 20, 2019 |
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 succiate
- Active ingredients
- Solifenacin succinate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bostal LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210281
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 35561-285_49fcc8a4-31aa-6975-e063-6394a90a9389SPL ID 49fcc8a4-31aa-6975-e063-6394a90a9389SPL set ID d155c739-6870-4938-ba91-8c1b4b90afe4RxCUI 477367, 477372UNII KKA5DLD701UPC 0335561286137, 0335561285130
- 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
N435561028500followed by a unit qualifier and the quantityPackage 35561-0285-00. 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 210281
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 Succinatesolifenacin succiate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-739 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-740 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bostal LLC | 35561-286 |