Prednisone

Product NDC
0440-8167
11-digit product format
004408167
Labeler code
0440
Product ID
0440-8167_10fdf7d3-6572-4254-985c-acc1915c9dff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
2009-08-03
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8167-01Prednisone100 in 1 BOTTLETABLET1003
0440-8167-05Prednisone500 in 1 BOTTLETABLET5003
0440-8167-10Prednisone1000 in 1 BOTTLETABLET10003
0440-8167-15Prednisone15 in 1 BOTTLETABLET153

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8167PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20131204_615fc25c-4a28-448f-ac8c-1fd269e65d61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN615fc25c-4a28-448f-ac8c-1fd269e65d613
312615prednisone 20 MG Oral TabletSCD615fc25c-4a28-448f-ac8c-1fd269e65d613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8167-0100440816701100 in 1 BOTTLEHistorical
0440-8167-0500440816705500 in 1 BOTTLEHistorical
0440-8167-10004408167101000 in 1 BOTTLEHistorical
0440-8167-150044081671515 in 1 BOTTLEHistorical