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PREDNISOLONE SODIUM PHOSPHATE

ANDA

PREDNISOLONE SODIUM PHOSPHATE | A203559 | EDENBRIDGE PHARMACEUTICALS LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PEDIAPRED(TE code: AA)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$2.43

per ml

Lowest NADAC/Unit

$0.1064

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
42799081201PREDNISOLONE 10 MG/5 ML SOLN	$2.43	ML	Generic	—	2026-04-22
42799081601PREDNISOLONE SOD PH 25 MG/5 ML	$0.7881	ML	Generic	—	2025-07-23
42799081501PREDNISOLONE 15 MG/5 ML SOLN	$0.1064	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (4 FSS)

Lowest Price

$29.32

Highest Price

$427.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
42799-0812-01PREDNISOLONE NA PHOSPHATE 10MG/5ML (A/F) SOLN	$340.20	FSS	THE JANZ CORPORATION	03/14/2030
42799-0813-01PREDNISOLONE NA PHOSPHATE 20MG/5ML (A/F) SOLN	$427.14	FSS	THE JANZ CORPORATION	03/14/2030
42799-0815-01PREDNISOLONE NA PHOSPHATE 15MG/5ML SOLN,ORAL	$29.32	FSS	AvKare, LLC	06/14/2028
42799-0816-01PREDNISOLONE NA PHOSPHATE 25MG/5ML (A/F) SOLN	$123.12	FSS	THE JANZ CORPORATION	03/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain5 active DMFs6 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCEPREDNISOLONE SODIUM PHOSPHATE

DMF 40511981

CURIA SPAIN SAUPREDNISOLONE SODIUM PHOSPHATE

DMF 226242009

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 238992010

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 297512015

FARMABIOS SPAPREDNISOLONE SODIUM PHOSPHATE

DMF 401172024

ORGANON INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 7581963

ANTIBIOTICOS SPAInactivePREDNISOLONE SODIUM PHOSPHATE BULK

DMF 23761974

DIOSYNTHInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 38191980

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactivePREDNISOLONE SODIUM PHOSPHATE, USP XX

DMF 46041982

PFIZER INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 93071991

NEWCHEM SPAInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 218222008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 10MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 20, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Dec 20, 2016

#003 — EQ 15MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Feb 6, 2023

#004 — EQ 25MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Feb 6, 2023