FDA.reportPublic FDA data

PREDNISONE

Product NDC
61919-342
11-digit product format
619190342
Labeler code
61919
Product ID
61919-342_9cac9b3f-a4f9-0219-e053-2995a90aadbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA083677
Marketing category
ANDA
Marketing start
2019-08-07
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-342-102020-01-31C16284748780-19d75b9d0-a6d8-f424-e053-dadaa90a57cePREDNISONE
61919-342-122020-01-31C16284748780-19d75b9d0-a6d8-f424-e053-dadaa90a57cePREDNISONE
61919-342-142020-01-31C16284748780-19d75b9d0-a6d8-f424-e053-dadaa90a57cePREDNISONE
61919-342-202020-01-31C16284748780-19d75b9d1-0351-f424-e053-dadaa90a57cePREDNISONE
61919-342-212020-01-31C16284748780-19d75b9d1-0351-f424-e053-dadaa90a57cePREDNISONE
61919-342-302020-01-31C16284748780-19d75b9d1-0351-f424-e053-dadaa90a57cePREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-342-10Prednisone10 in 1 BOTTLETABLET102
61919-342-12Prednisone12 in 1 BOTTLETABLET122
61919-342-14Prednisone14 in 1 BOTTLETABLET142
61919-342-20PREDNISONE20 in 1 BOTTLETABLET202
61919-342-21PREDNISONE21 in 1 BOTTLETABLET212
61919-342-30PREDNISONE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-342-05EA - Each61919-342ad528226-799f-4026-8b16-68330702311312019-09-05
61919-342-10EA - Each61919-3420836427a-3050-4880-af7f-1a695c74035a12015-09-10
61919-342-20EA - Each61919-34210a61837-ef03-4e57-b628-fe7ca686aceb12018-05-09
61919-342-21EA - Each61919-3427a1463cb-c1b4-42d5-848b-24f8e7478ece12019-08-06

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-342PREDNISONE TABLET [DIRECT RX]2Legacy NDC, 3 package rows20150825_9547efb2-4f56-4556-b15c-daff3683ce13.zip
61919-342PREDNISONE TABLET [DIRECTRX]2Legacy NDC, 3 package rows20151106_60aa55bf-169b-4cf3-b5d9-c3bebef6c4ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN60aa55bf-169b-4cf3-b5d9-c3bebef6c4ae2
312615predniSONE 20 MG Oral TabletPSN9547efb2-4f56-4556-b15c-daff3683ce132
312615prednisone 20 MG Oral TabletSCD60aa55bf-169b-4cf3-b5d9-c3bebef6c4ae2
312615prednisone 20 MG Oral TabletSCD9547efb2-4f56-4556-b15c-daff3683ce132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-342-05619190342055 TABLET in 1 BOTTLE (61919-342-05) 5 tablet2019-08-070000-00-00NoNoCurrent
61919-342-106191903421010 in 1 BOTTLEHistorical
61919-342-126191903421212 in 1 BOTTLEHistorical
61919-342-146191903421414 in 1 BOTTLEHistorical
61919-342-206191903422020 in 1 BOTTLEHistorical
61919-342-216191903422121 in 1 BOTTLEHistorical
61919-342-306191903423030 in 1 BOTTLEHistorical