Duloxetine
NDC Package 57237-019-30
Package Information
Duloxetine is delayed-release capsules are indicated for the treatment of:Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adultsChronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-019 and is authorized under FDA application ANDA090778.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57237 - Rising Pharma Holdings, Inc.
- 57237-019 - Duloxetine
- 57237-019-30 - 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
- 57237-019 - Duloxetine
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (57237-019). Click a package code to view its specific billing and regulatory data.
* 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 57237-019-30 identifies a specific commercial package of 30 capsule, delayed release in 1 bottle of Duloxetine, labeled by Rising Pharma Holdings, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rising Pharma Holdings, Inc. on December 11, 2013. The current certification is valid through March 31, 2026.
How is this Rising Pharma Holdings, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237001930. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
