Prescription drug · ANDA
solifenacin succinate NDC 31722-028
Solifenacin succinate 10 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-028-30 | 3172200283031722002830 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-028-30)Marketed from Jun 15, 2022 | |
| 31722-028-31 | 3172200283131722002831 | 10 BLISTER PACK in 1 CARTON (31722-028-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-028-32)Marketed from Jun 15, 2022 | |
| 31722-028-90 | 3172200289031722002890 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-028-90)Marketed from Jun 15, 2022 |
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
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215761
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 31722-028_e52cdf06-9178-ab2f-e053-2a95a90af2b3SPL ID e52cdf06-9178-ab2f-e053-2a95a90af2b3SPL set ID 6479d24f-373e-4c9e-abaf-349f90a2bbb1RxCUI 477367, 477372UNII KKA5DLD701UPC 0331722028301, 0331722027908, 0331722027304, 0331722028905
- 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
N431722002830followed by a unit qualifier and the quantityPackage 31722-0028-30. 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 . This label includes a boxed warning.
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.
About NDC 31722-028
- What is NDC 31722-028?
- 31722-028 is the product NDC for solifenacin succinate, Solifenacin succinate 10 mg/1 tablet, film coated, listed with the FDA by Camber 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 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 |
| Solifenacin succinate | Solifenacin succinate 5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0591-3795 | 00591-3795-1900591-3795-30 |
Other NDCs under ANDA 215761
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 | Camber Pharmaceuticals, Inc. | 31722-027 |