Prescription drug · ANDA
Solifenacin Succinate (Solifenacin succiate) NDC 42291-739
Solifenacin succinate 5 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-739-30 | 4229107393042291073930 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-739-30)Marketed from Oct 1, 2020 | |
| 42291-739-90 | 4229107399042291073990 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-739-90)Marketed from Oct 1, 2020 |
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
- AvKARENDC labeler code 42291
- 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 42291-739_4874ff98-e2e2-226a-e063-6394a90a30f5SPL ID 4874ff98-e2e2-226a-e063-6394a90a30f5SPL set ID b0a0651e-1488-36b7-e053-2995a90a3f14RxCUI 477367, 477372UNII KKA5DLD701
- 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
N442291073930followed by a unit qualifier and the quantityPackage 42291-0739-30. 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.
About NDC 42291-739
- What is NDC 42291-739?
- 42291-739 is the product NDC for Solifenacin Succinate (solifenacin succiate), Solifenacin succinate 5 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Solifenacin Succinate (Solifenacin succiate).
- What is the active ingredient?
- Solifenacin succinate.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. 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 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 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 | Bostal LLC | 35561-285 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | Bostal LLC | 35561-286 |
| Solifenacin Succinate | Solifenacin succinate 10 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-740 |