Prescription drug · ANDA
Solifenacin Succinate NDC 50228-428
Solifenacin succinate 10 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-428-05 | 5022804280550228042805 | 500 TABLET, FILM COATED in 1 BOTTLE (50228-428-05)Marketed from May 20, 2019 | |
| 50228-428-30 | 5022804283050228042830 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-428-30)Marketed from May 20, 2019 | |
| 50228-428-90 | 5022804289050228042890 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-428-90)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 succinate
- Active ingredients
- Solifenacin succinate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211657
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 50228-428_b9432117-2521-7360-e053-2a95a90acd2aSPL ID b9432117-2521-7360-e053-2a95a90acd2aSPL set ID a6f154d9-7463-4b80-b80e-c06a06e36141RxCUI 477367, 477372UNII KKA5DLD701UPC 0350228428903, 0350228428057, 0350228428309, 0350228427050, 0350228427906, 0350228427302
- 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
N450228042805followed by a unit qualifier and the quantityPackage 50228-0428-05. 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 is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is 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.
About NDC 50228-428
- What is NDC 50228-428?
- 50228-428 is the product NDC for Solifenacin Succinate, Solifenacin succinate 10 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Solifenacin Succinate.
- What is the active ingredient?
- Solifenacin succinate.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Solifenacin Succinate?
- 50 other product NDCs are listed under this name. See all Solifenacin Succinate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Solifenacin Succinate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Solifenacin succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0831 | 72303-0831-0172303-0831-02 |
| Solifenacin succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0832 | 72303-0832-0172303-0832-02 |
| solifenacin succinate | Solifenacin succinate 5 mg/1 | Tablet, CoatedOral | Macleods Pharmaceuticals Limited | 33342-148 | 33342-0148-0733342-0148-10 |
| solifenacin succinate | Solifenacin succinate 10 mg/1 | Tablet, CoatedOral | Macleods Pharmaceuticals Limited | 33342-149 | 33342-0149-0733342-0149-10 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-878 | 65862-0878-0365862-0878-3065862-0878-90+1 more |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-879 | 65862-0879-0365862-0879-3065862-0879-90+1 more |
| solifenacin succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-027 | 31722-0027-3031722-0027-3131722-0027-90 |
| solifenacin succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-028 | 31722-0028-3031722-0028-3131722-0028-90 |
| Solifenacin Succinatesolifenacin succiate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-739 | 42291-0739-3042291-0739-90 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-740 | 42291-0740-3042291-0740-90 |
Other NDCs under ANDA 211657
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 | ScieGen Pharmaceuticals, Inc. | 50228-427 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-471 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-472 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8532 |
| Solifenacin Succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2423 |