Prednisolone Sodium Phosphate
NDC Package 0603-9388-56
Package Information
Prednisolone Sodium Phosphate is prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. Marketed by Qualitest Pharmaceuticals, this product is identified by NDC 0603-9388 and is authorized under FDA application ANDA079010.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0603 - Qualitest Pharmaceuticals
- 0603-9388 - Prednisolone Sodium Phosphate
- 0603-9388-56 - 237 mL in 1 BOTTLE
- 0603-9388 - Prednisolone Sodium Phosphate
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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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0603-9388-56 identifies a specific commercial package of 237 ml in 1 bottle of Prednisolone Sodium Phosphate, labeled by Qualitest Pharmaceuticals. 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 Qualitest Pharmaceuticals on May 26, 2009. The current certification is valid through February 27, 2014.
What are the primary indications for this medication?
Prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.
How is this Qualitest Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00603938856. 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 Labeler segment to maintain the 5-4-2 structure.