FDA.reportPublic FDA data

PREDNISONE

Product NDC
61919-404
11-digit product format
619190404
Labeler code
61919
Product ID
61919-404_9cac41a7-08ea-191c-e053-2a95a90af44d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA088832
Marketing category
ANDA
Marketing start
2014-01-01
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
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
61919-404-212023-01-30C16284748780-1f386c649-b427-0266-e053-dadaa90a7c1aPREDNISONE
61919-404-302023-01-30C16284748780-1f386c649-b427-0266-e053-dadaa90a7c1aPREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-404-21PREDNISONE21 in 1 BOTTLETABLET213
61919-404-30PREDNISONE30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-404-21EA - Each61919-40487e934cd-a5bd-46a3-9819-bbdd000ed7cb12014-07-02
61919-404-30EA - Each61919-404383d4292-a5a0-4e79-8106-7b7101a9cd7212014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-404PREDNISONE TABLET PREDNISONE TABLET [DIRECT RX]3Legacy NDC, 2 package rows20200122_a10ce97b-3efc-443f-9c76-a2bfe2c57be3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNa10ce97b-3efc-443f-9c76-a2bfe2c57be33
312617predniSONE 5 MG Oral TabletPSNa10ce97b-3efc-443f-9c76-a2bfe2c57be33
198145prednisone 10 MG Oral TabletSCDa10ce97b-3efc-443f-9c76-a2bfe2c57be33
312617prednisone 5 MG Oral TabletSCDa10ce97b-3efc-443f-9c76-a2bfe2c57be33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-404-216191904042121 TABLET in 1 BOTTLE (61919-404-21) 21 tablet2015-01-010000-00-00NoNoCurrent
61919-404-306191904043030 TABLET in 1 BOTTLE (61919-404-30) 30 tablet2015-01-010000-00-00NoNoCurrent