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Active ingredient

Prednisone

316 finished FDA listings contain Prednisone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
PREDNISONE, PREDNISONE ACETATE
Dosage forms
Solution, Solution, Concentrate, Tablet, Tablet, Delayed Release
Routes
Oral
Manufacturers / labelers
46
Strengths listed
1 mg/1 · 10 mg/1 · 2 mg/1 · 2.5 mg/1 · 20 mg/1 · 5 mg/1 · 5 mg/5ml · 5 mg/ml · 50 mg/1
Brand names in FDA listings
Prednisone Delayed Release, Prednisone Tablets, Usp, 10 Mg, Prednisone Tablets, Usp, 20 Mg, Prednisone Tablets, Usp, 5 Mg

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 8640

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.

ApplicationSponsorOriginal approvalListings
ANDA 080356WATSON LABS1972-01-175
ANDA 080352HIKMA1972-04-2125
ANDA 083677MYLAN1974-02-262
ANDA 084275CHARTWELL MOLECULAR1974-06-271
ANDA 085161WATSON LABS1976-11-118
ANDA 085162WATSON LABS1976-11-127
ANDA 088703HIKMA1984-11-082
ANDA 088810HIKMA1985-02-201
ANDA 040362JUBILANT CADISTA2001-08-2920
ANDA 040256PH HEALTH2002-07-1221
ANDA 040392PH HEALTH2003-02-123
ANDA 040584PH HEALTH2004-12-215
ANDA 040581PH HEALTH2004-12-214
ANDA 040611JUBILANT CADISTA2005-06-061
ANDA 211496QUAGEN2018-12-281
ANDA 211575NOVITIUM PHARMA2019-11-1529
ANDA 213385AMNEAL2020-06-167
ANDA 213386AMNEAL2020-06-2415
ANDA 210785STRIDES PHARMA2020-09-022
ANDA 208412STRIDES PHARMA2021-02-1159
ANDA 215246NOVITIUM PHARMA2021-07-061
ANDA 215671AUROBINDO PHARMA LTD2021-11-163
ANDA 215672AUROBINDO PHARMA LTD2022-03-2839
ANDA 212629POINTVIEW HLDINGS2023-12-0525
ANDA 219477DR REDDYS2025-10-014
ANDA 218035DR REDDYS2026-06-261

Official labeling on DailyMed

Showing the 12 most recent of 245 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.