Active ingredient
Prednisolone
59 finished FDA listings contain Prednisolone as their only active ingredient; 2 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PREDNISOLONE, PREDNISOLONE ACETATE, PREDNISOLONE SODIUM PHOSPHATE
- Dosage forms
- Solution, Solution/ Drops, Suspension/ Drops, Syrup, Tablet, Tablet, Orally Disintegrating
- Routes
- Ophthalmic, Oral
- Manufacturers / labelers
- 34
- Strengths listed
- 1.2 mg/ml · 10 mg/1 · 10 mg/5ml · 10 mg/ml · 15 mg/1 · 15 mg/5ml · 20 mg/5ml · 25 mg/5ml · 30 mg/1 · 5 mg/1 · 5 mg/5ml
- Brand names in FDA listings
- Orapred Odt, Pred Forte, Pred Mild, Prednisolone, Prednisolone Sodium Phosphate Odt, Prednisolone Sodium Phosphate Oral Solution
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8638
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017100 | ABBVIE | 1972-11-10 | 1 |
| NDA 017011 | ABBVIE | 1973-05-30 | 7 |
| NDA 017469 | SANDOZ | 1973-07-10 | 3 |
| ANDA 080531 | CHARTWELL MOLECULAR | 1974-05-31 | 1 |
| NDA 019157 | PAI HOLDINGS | 1986-05-28 | 2 |
| ANDA 040070 | BAUSCH AND LOMB INC | 1994-07-29 | 1 |
| ANDA 040323 | CHARTWELL RX | 1999-05-13 | 3 |
| ANDA 075988 | CHARTWELL RX | 2004-05-25 | 2 |
| ANDA 076913 | PHARM ASSOC | 2005-04-25 | 6 |
| ANDA 040571 | PHARM ASSOC | 2005-08-25 | 2 |
| NDA 021959 | ADVANZ PHARMA | 2006-06-01 | 6 |
| ANDA 040775 | LANNETT CO INC | 2007-09-21 | 1 |
| ANDA 078465 | PHARM ASSOC | 2008-03-07 | 1 |
| ANDA 078988 | PHARM ASSOC | 2008-06-09 | 1 |
| ANDA 091396 | MISSION PHARMA | 2010-09-13 | 1 |
| ANDA 203559 | EDENBRIDGE PHARMS | 2016-12-20 | 9 |
| ANDA 216715 | AMNEAL | 2022-10-25 | 1 |
| ANDA 215673 | AUROBINDO PHARMA LTD | 2023-03-17 | 1 |
| ANDA 218083 | ZHEJIANG XIANJU | 2024-05-02 | 2 |
| ANDA 216935 | LUPIN | 2024-08-02 | 3 |
| ANDA 218256 | AMNEAL | 2025-06-11 | 3 |
| ANDA 219509 | TP ANDA HOLDINGS | 2025-06-23 | 2 |
Official labeling on DailyMed
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 4 · 2026-09-10
- PREDNISOLONE (PREDNISOLONE ORAL) SOLUTION [TRUPHARMA, LLC] · version 1 · 2026-09-04
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-08-20
- PREDNISOLONE ACETATE SUSPENSION/ DROPS [A-S MEDICATION SOLUTIONS] · version 7 · 2026-08-05
- PREDNISOLONE ACETATE SUSPENSION/ DROPS [SPORTPHARM LLC] · version 1 · 2026-07-24
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 2 · 2026-07-13
- PREDNISOLONE (PREDNISOLONE ORAL) SOLUTION [TULEX PHARMACEUTICALS INC] · version 8 · 2026-07-10
- PREDNISOLONE ACETATE SUSPENSION/ DROPS [SPORTPHARM LLC] · version 2 · 2026-04-27
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [KESIN PHARMA] · version 1 · 2026-03-05
- PREDNISOLONE ACETATE SUSPENSION/ DROPS [A-S MEDICATION SOLUTIONS] · version 3 · 2026-03-04
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [CHARTWELL RX, LLC.] · version 11 · 2026-02-16
- PREDNISOLONE SODIUM PHOSPHATE SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-02-11
Showing the 12 most recent of 49 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.