Prednisone

Product NDC
0440-8165
11-digit product format
004408165
Labeler code
0440
Product ID
0440-8165_79e65904-d281-4e17-9ef2-640b731046a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA080356
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-8165-122020-01-31C16284748780-19d75b9cf-d9e2-f424-e053-dadaa90a57cePrednisone Tablets USP Revised: September 2008 Rx only 173666

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-8165-12Prednisone12 in 1 BOTTLE, PLASTICTABLET121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-8165PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_c72692dd-8f94-434b-b089-c798b90e4213.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNc72692dd-8f94-434b-b089-c798b90e42131
312617prednisone 5 MG Oral TabletSCDc72692dd-8f94-434b-b089-c798b90e42131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-8165-120044081651212 in 1 BOTTLE, PLASTICHistorical