Suppliers and packagers for PEDIAPRED

PEDIAPRED

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pai Holdings	PEDIAPRED	prednisolone sodium phosphate	SOLUTION;ORAL	019157	NDA	Seton Pharmaceuticals, LLC	13925-166-04	120 mL in 1 BOTTLE (13925-166-04)	2013-10-18

Pediapred (Prednisolone Sodium Phosphate) Suppliers: Who Manufactures and Supplies the Drug?

Last updated: April 23, 2026

What is Pediapred and how is it supplied in the US?

Pediapred is a pediatric formulation of prednisolone sodium phosphate. In the US market, it is supplied as an oral liquid under the “Pediapred” brand.

In FDA submissions and labeling, the active ingredient and dosage form are consistently defined as:

• Active ingredient: prednisolone sodium phosphate
• Dosage form: oral solution (liquid)

FDA’s Orange Book lists the reference drug and product-specific manufacturing/labeling details through associated application records and product attributes. These records are the backbone for identifying supplier/manufacturer lines of responsibility in the US supply chain. Source: FDA Orange Book entries for Pediapred prednisolone sodium phosphate oral solution. [1]

Which companies supply Pediapred products in the US?

FDA Orange Book identifies drug products and associates them with specific application holders (and product entries that map to manufacturing responsibility within the application). For “Pediapred” prednisolone sodium phosphate oral solution, the supplier/manufacturer attribution is tied to the brand’s FDA-reviewed drug product record. Source: FDA Orange Book, Pediapred entries. [1]

US market supplier/manufacturer attribution (Orange Book-linked)

Item	Supplier / manufacturer line in FDA Orange Book	Evidence
Pediapred (prednisolone sodium phosphate) oral solution	Orange Book application-linked holder for the Pediapred drug product entry	FDA Orange Book product record for Pediapred prednisolone sodium phosphate oral solution. [1]

Are there multiple strengths and product configurations with different suppliers?

Pediapred is typically marketed in distinct strengths and sometimes different packaging/labeling configurations. In US regulatory terms, each product configuration is represented by a discrete Orange Book product record. If a company changes manufacturing site, formulation, or packaging, the Orange Book product record set can reflect that through distinct product attributes.

FDA Orange Book is the source-of-record for whether the market has one or multiple product entries and how they map to application-level responsibility. Source: FDA Orange Book, Pediapred prednisolone sodium phosphate oral solution product list. [1]

Who manufactures the active ingredient and bulk drug substance?

Supplier mapping for the active pharmaceutical ingredient (API) depends on whether the API manufacturer is disclosed in FDA labeling, drug master files, DMF-linked Orange Book references, or supplier qualification documents. The public Orange Book record for a branded product generally confirms the drug product application and product attributes, but it does not reliably list every API supplier in a way that supports a complete and accurate “who makes the API” list for Pediapred without relying on DMF linkages that are not always presented in a directly attributable format in public records. Source: FDA Orange Book. [1]

Accordingly, the only defensible “supplier” list without overreaching is the drug product application holder/manufacturer attribution that Orange Book provides for the marketed oral solution products. Source: FDA Orange Book Pediapred entries. [1]

Supplier mapping through the FDA regulatory record: how it works

For business planning, the operationally useful supplier view is:

• Drug product application holder: the company tied to the marketed drug product record in the Orange Book.
• Manufacturing responsibility: typically defined at the application and facility level within FDA review files and label/compendial listings, but the public record is most consistently used via the Orange Book product record.
• Strength/configuration variance: represented by separate Orange Book product records if the market includes distinct strengths and/or packaging configurations.

Source: FDA Orange Book structure and product record entries for Pediapred. [1]

Key Takeaways

• Pediapred is supplied as prednisolone sodium phosphate oral solution, and supplier attribution in the US is anchored to the FDA Orange Book drug product records for the brand. [1]
• The reliable public supplier/manufacturer identification is the Orange Book application-linked holder for each Pediapred product entry, which also covers differences by strength/configuration when separate records exist. [1]
• API supplier identification is not consistently disclosed in public Orange Book product records in a way that supports a complete, defensible list of API manufacturers for Pediapred from public sources alone. [1]

FAQs

1. Is Pediapred the same as prednisolone sodium phosphate?
   Yes. Pediapred is the brand name for prednisolone sodium phosphate in an oral liquid dosage form. [1]

2. Where can I verify the US supplier/manufacturer attribution for Pediapred?
   Verify via the FDA Orange Book product record for Pediapred prednisolone sodium phosphate oral solution. [1]

3. Do different strengths of Pediapred list different suppliers?
   They can. In the Orange Book, strengths/configurations may appear as distinct product entries with their own product attributes. Supplier attribution follows the Orange Book product record. [1]

4. Does Orange Book list the API (bulk drug substance) manufacturer for Pediapred?
   Not consistently in a directly attributable way for every supplier, because public Orange Book product records focus on the drug product application and product attributes. [1]

5. Is Pediapred still an active branded product in the US?
   Availability and current status are reflected through the FDA Orange Book listing for Pediapred prednisolone sodium phosphate oral solution. [1]

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References

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA / Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Pediapred; prednisolone sodium phosphate oral solution entries). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/ (search within Orange Book for Pediapred prednisolone sodium phosphate oral solution)