Sulfasalazine
NDC Package 71610-577-80
Package Information
Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-577 and is authorized under FDA application ANDA085828.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 71610 - Aphena Pharma Solutions - Tennessee, Llc
- 71610-577 - Sulfasalazine
- 71610-577-80 - 180 TABLET in 1 BOTTLE, PLASTIC
- 71610-577 - Sulfasalazine
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 (71610-577). Click a package code to view its specific billing and regulatory data.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 71610-577-80 identifies a specific commercial package of 180 tablet in 1 bottle, plastic of Sulfasalazine, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 180 billable units per package. 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 Aphena Pharma Solutions - Tennessee, Llc on October 01, 1982. The current certification is valid through July 31, 2021.
What are the primary indications for this medication?
Sulfasalazine is used to treat a certain type of bowel disease called ulcerative colitis. This medication does not cure this condition, but it helps decrease symptoms such as fever, stomach pain, diarrhea, and rectal bleeding. After an attack is treated, sulfasalazine is also used to increase the amount of time between attacks. This medication works by reducing irritation and swelling in the large intestines. In addition, delayed-release tablets of sulfasalazine are used to treat rheumatoid arthritis. Sulfasalazine helps to reduce joint pain, swelling, and stiffness. Early treatment of rheumatoid arthritis with sulfasalazine helps to reduce/prevent further joint damage so you can do more of your normal daily activities. This medication is used with other drugs, rest, and physical therapy in patients who have not responded to other medications (salicylates, nonsteroidal anti-inflammatory drugs-NSAIDs).
How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610057780. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 180 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.