FDA.reportPublic FDA data

Prednisone

Product NDC
50436-4326
11-digit product format
504364326
Labeler code
50436
Product ID
50436-4326_81d67588-8000-4cc0-8a53-2960fd1fd224
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA083677
Marketing category
ANDA
Marketing start
1974-02-26
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-4326-22020-01-31C16284748780-19d75b9d1-0897-f424-e053-dadaa90a57cePrednisone Tablets, USP Rev. 11/10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4326-2Prednisone30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4326-2EA - Each50436-4326d98e3c78-a6cc-4b7b-8017-23a137ba3a8112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [UNIT DOSE SERVICES]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [UNIT DOSE SERVICES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [UNIT DOSE SERVICES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4326PREDNISONE TABLET [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20120618_c308ffd5-208e-4661-8451-2c6ea6594d08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNc308ffd5-208e-4661-8451-2c6ea6594d082
312615prednisone 20 MG Oral TabletSCDc308ffd5-208e-4661-8451-2c6ea6594d082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4326-25043643260230 in 1 BOTTLEHistorical