PREDNISONE

Product NDC
68788-8819
11-digit product format
687888819
Labeler code
68788
Product ID
68788-8819_94d82acb-ff31-492f-bd51-b23e15d881d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA215672
Marketing category
ANDA
Marketing start
2025-01-23
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data

Finished product
Yes
Brand name base
PREDNISONE
Listing expiration
2026-12-31

Related Records

Active Ingredients

IngredientStrength
PREDNISONE20 mg/1

Harmonized Identifiers

FieldValues
UniiVB0R961HZT
Rxcui312615

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
VB0R961HZTPREDNISONE53-03-2PREDNISONE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8819-16878888190110 TABLET in 1 BOTTLE (68788-8819-1) 10 tablet2025-01-23NoNoCurrent
68788-8819-26878888190220 TABLET in 1 BOTTLE (68788-8819-2) 20 tablet2025-01-23NoNoCurrent
68788-8819-36878888190330 TABLET in 1 BOTTLE (68788-8819-3) 30 tablet2025-01-23NoNoCurrent
68788-8819-46878888190418 TABLET in 1 BOTTLE (68788-8819-4) 18 tablet2025-01-23NoNoCurrent
68788-8819-56878888190515 TABLET in 1 BOTTLE (68788-8819-5) 15 tablet2025-01-23NoNoCurrent
68788-8819-86878888190821 TABLET in 1 BOTTLE (68788-8819-8) 21 tablet2025-01-23NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prednisone Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2025-01-23HUMAN PRESCRIPTION DRUG LABEL1