FDA.reportPublic FDA data

PREDNISONE

Product NDC
61919-365
11-digit product format
619190365
Labeler code
61919
Product ID
61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040584
Marketing category
ANDA
Marketing start
2014-01-01
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREDNISONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617, 763181

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
61919-365-212025-01-30C16284748780-12cef2736-a9c2-d83d-e063-dadaa90ab31fPREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-365-21PREDNISONE21 in 1 DOSE PACKTABLET215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-365-21EA - Each61919-36504d02470-7e6f-41b5-9278-d043e0f72f0a12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [DIRECT RX]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [DIRECT RX]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-365PREDNISONE TABLET [DIRECT RX]4Current NDC, Legacy NDC, 1 package rows20230113_2a053775-6f6a-455e-b9a8-8b60e6062db3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCK2a053775-6f6a-455e-b9a8-8b60e6062db35
312617predniSONE 5 MG Oral TabletPSN2a053775-6f6a-455e-b9a8-8b60e6062db35
763181predniSONE 5 MG Tablet 21 Count PackPSN2a053775-6f6a-455e-b9a8-8b60e6062db35
312617prednisone 5 MG Oral TabletSCD2a053775-6f6a-455e-b9a8-8b60e6062db35
763181Prednisone 5 MG Oral Tablet 21 Count PackSY2a053775-6f6a-455e-b9a8-8b60e6062db35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-365-216191903652121 TABLET in 1 DOSE PACK (61919-365-21) 21 tablet2014-01-010000-00-00NoNoCurrent