Prescription drug · ANDA
solifenacin succinate NDC 68462-387
Solifenacin succinate 10 mg/1 · Tablet, Film coated, Extended release · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-387-14 | 6846203871468462038714 | 10 BLISTER PACK in 1 CARTON (68462-387-14) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from May 20, 2019 | |
| 68462-387-30 | 6846203873068462038730 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-30)Marketed from May 20, 2019 | |
| 68462-387-90 | 6846203879068462038790 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-387-90)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, Extended release
- Route
- Oral
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209239
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Muscarinic Antagonists (Mechanism)
- Identifiers
- Product ID 68462-387_85807e7f-3f25-4df8-812e-fa6b281d559bSPL ID 85807e7f-3f25-4df8-812e-fa6b281d559bSPL set ID 010c0657-c907-477f-8bd7-5d455a5f50ebRxCUI 477367, 477372UNII KKA5DLD701UPC 0368462386309
- 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
N468462038714followed by a unit qualifier and the quantityPackage 68462-0387-14. 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.
About NDC 68462-387
- What is NDC 68462-387?
- 68462-387 is the product NDC for solifenacin succinate, Solifenacin succinate 10 mg/1 tablet, film coated, extended release, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. 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?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 209239
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 | Glenmark Pharmaceuticals Inc., USA | 68462-386 |