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PredniSONE

Prescription ANDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
PredniSONE
Generic name
PredniSONE
Dosage form
Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Hikma Pharmaceuticals USA Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Prednisone 5 mg/5mL 198144 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
088703
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 8, 1984
Sponsor
HIKMA
Products on application
1
Submissions recorded
23
Products approved under application 088703.
Product Trade name Form Strength Ingredient Status TE Flags
088703-001 PREDNISONE SOLUTION PREDNISONE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 088703.
Type No. Action Status Date Review
Supplement 32 Labeling Approved June 5, 2024 Standard
Supplement 31 Labeling Approved May 16, 2024 Standard
Supplement 25 Manufacturing (CMC) Approved November 27, 2002 —
Supplement 24 Labeling Approved November 27, 2002 —
Supplement 22 Manufacturing (CMC) Approved November 19, 1999 —
Supplement 23 Manufacturing (CMC) Approved December 1, 1998 —
Supplement 20 Manufacturing (CMC) Approved January 15, 1998 —
Supplement 19 Manufacturing (CMC) Approved January 15, 1998 —
Supplement 16 Labeling Approved December 13, 1996 —
Supplement 15 Manufacturing (CMC) Approved December 13, 1996 —
Supplement 18 Manufacturing (CMC) Approved August 28, 1996 —
Supplement 17 Labeling Approved July 13, 1995 —
Supplement 14 Labeling Approved February 22, 1995 —
Supplement 13 Labeling Approved October 7, 1994 —
Supplement 12 Labeling Approved March 30, 1994 —
Supplement 10 Manufacturing (CMC) Approved June 15, 1992 —
Supplement 11 Labeling Approved June 5, 1991 —
Supplement 9 Labeling Approved February 21, 1990 —
Supplement 8 Labeling Approved October 13, 1989 —
Supplement 6 Manufacturing (CMC) Approved May 11, 1988 —
Supplement 5 Manufacturing (CMC) Approved May 11, 1988 —
Supplement 4 Labeling Approved February 23, 1988 —
Original application 1 Approved November 8, 1984 —

Adverse event reports

Source: openFDA FAERS
499,957
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: PREDNISONE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
17856-3722-1 17856-3722 Atlantic Biologicals Corps 5 mL in 1 CUP (17856-3722-1) May 5, 2016
17856-3722-2 17856-3722 Atlantic Biologicals Corps 45 SYRINGE in 1 CASE (17856-3722-2) / 5 mL in 1 SYRINGE September 17, 2026
17856-3722-3 17856-3722 Atlantic Biologicals Corps 45 SYRINGE in 1 CASE (17856-3722-3) / 5 mL in 1 SYRINGE September 17, 2026
0054-3722-50 0054-3722 Hikma Pharmaceuticals USA Inc. 120 mL in 1 BOTTLE (0054-3722-50) December 13, 1996
0054-3722-63 0054-3722 Hikma Pharmaceuticals USA Inc. 500 mL in 1 BOTTLE (0054-3722-63) November 8, 1984
17856-3722 17856-3722 Atlantic Biologicals Corps — December 13, 1986
0054-3722 0054-3722 Hikma Pharmaceuticals USA Inc. — November 8, 1984

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.