Prednisone

Product NDC
50436-4325
11-digit product format
504364325
Labeler code
50436
Product ID
50436-4325_2b6c52d4-8fbc-4b9c-ab10-48d9291eb5f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA088832
Marketing category
ANDA
Marketing start
1985-12-04
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
50436-4325-12020-01-31C16284748780-19d75b9d0-5797-f424-e053-dadaa90a57cePrednisone Tablets, USP Rev. 11/10
50436-4325-22020-01-31C16284748780-19d75b9d0-5797-f424-e053-dadaa90a57cePrednisone Tablets, USP Rev. 11/10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4325-1Prednisone30 in 1 BOTTLETABLET304
50436-4325-2Prednisone21 in 1 BOTTLETABLET214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4325-2EA - Each50436-432501ca74b8-9c36-4ae9-834e-b4f97fb8e9d312014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]4
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [UNIT DOSE SERVICES]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [UNIT DOSE SERVICES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [UNIT DOSE SERVICES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [UNIT DOSE SERVICES]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [UNIT DOSE SERVICES]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [UNIT DOSE SERVICES]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [UNIT DOSE SERVICES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4325PREDNISONE TABLET [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20131006_f02ffa5a-1292-4ec9-bb54-e2cd2db4be74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCKf02ffa5a-1292-4ec9-bb54-e2cd2db4be744
198145predniSONE 10 MG Oral TabletPSNf02ffa5a-1292-4ec9-bb54-e2cd2db4be744
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSNf02ffa5a-1292-4ec9-bb54-e2cd2db4be744
198145prednisone 10 MG Oral TabletSCDf02ffa5a-1292-4ec9-bb54-e2cd2db4be744
763185Prednisone 10 MG Oral Tablet 21 Count PackSYf02ffa5a-1292-4ec9-bb54-e2cd2db4be744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4325-15043643250130 in 1 BOTTLEHistorical
50436-4325-25043643250221 in 1 BOTTLEHistorical