PREDNISONE

Product NDC
42708-195
11-digit product format
427080195
Labeler code
42708
Product ID
42708-195_4aa28a4b-dd13-2936-e063-6294a90a0b9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
QPharma, Inc.
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREDNISONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42708-195-10PREDNISONE10 in 1 BOTTLE, PLASTICTABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN4aa286e3-e272-8095-e063-6394a90ae8711
312615prednisone 20 MG Oral TabletSCD4aa286e3-e272-8095-e063-6394a90ae8711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42708-195-104270801951010 TABLET in 1 BOTTLE, PLASTIC (42708-195-10) 10 tablet2026-02-13YesNoHistorical