Solifenacin Succinate Tablet, Coated
NDC Package 62332-192-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Solifenacin Succinate tablets is solifenacin is used to treat an overactive bladder. This formulation utilizes a tablet, coated delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-192 and is authorized under FDA application ANDA205575.

Identification & Billing

NDC Package Code
62332-192-91
Package Description
1000 TABLET, COATED in 1 BOTTLE
Product Code
62332-192
11-Digit Billing Format
62332019291
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Solifenacin Succinate
Non-Proprietary Name
Solifenacin Succinate
Substance Name
Solifenacin Succinate
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SOLIFENACIN SUCCINATE 5 mg/1
Pharmacologic Class
Usage Information
Solifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA205575
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62332-192). Click a package code to view its specific billing and regulatory data.

62332-192-08
80 TABLET, COATED in 1 CARTON
62332-192-30
30 TABLET, COATED in 1 BOTTLE
62332-192-90
90 TABLET, COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62332-192-91 identifies a specific commercial package of 1000 tablet, coated in 1 bottle of Solifenacin Succinate, a human prescription drug labeled by Alembic Pharmaceuticals Inc.. This tablet, coated is formulated for oral use and contains solifenacin succinate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Alembic Pharmaceuticals Inc. on May 20, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Solifenacin is used to treat an overactive bladder. By relaxing the muscles in the bladder, solifenacin improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332019291. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
62332-192-91
11-Digit CMS (5-4-2)
62332-0192-91

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.