FDA.reportPublic FDA data

PREDNISONE

Product NDC
50090-5656
11-digit product format
500905656
Labeler code
50090
Product ID
50090-5656_ec896ab7-c695-44bb-98ff-6e0381b8d768
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210525
Marketing category
ANDA
Marketing start
2018-12-04
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
2022-12-31
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
50090-5656-02023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-12023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-22023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-42023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-52023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-72023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-5656-82023-01-30C16284748780-1f386c649-a83f-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5656-0PREDNISONE10 in 1 BOTTLETABLET101
50090-5656-1PREDNISONE15 in 1 BOTTLETABLET151
50090-5656-2PREDNISONE21 in 1 BOTTLETABLET211
50090-5656-4PREDNISONE50 in 1 BOTTLETABLET501
50090-5656-5PREDNISONE30 in 1 BOTTLETABLET301
50090-5656-7PREDNISONE100 in 1 BOTTLETABLET1001
50090-5656-8PREDNISONE40 in 1 BOTTLETABLET401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5656-0EA - Each50090-565684cf2c1f-fdd8-448f-b0f9-6fb884f8b3f612022-12-07
50090-5656-1EA - Each50090-565665243f2d-5d38-4f3a-83e4-d49ce1c5f2cc12022-12-07
50090-5656-2EA - Each50090-56563acd6d57-d757-4f4e-b0a7-eb860481c59112022-12-07
50090-5656-4EA - Each50090-56569e7d5fe7-a4b9-43ca-ab40-cb3ecc86f81312022-12-07
50090-5656-5EA - Each50090-56562f17d365-2d3b-47ee-a1ad-d1195fb6b86312022-10-06
50090-5656-7EA - Each50090-56567a3f97ad-946e-4b92-a886-9fe28dbc3e2212022-10-06
50090-5656-8EA - Each50090-5656603d6b35-08ee-4f47-989a-b556926284d512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5656PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 7 package rows20210918_8e911f16-3db5-4f7e-b7da-4e424b2d6c94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN8e911f16-3db5-4f7e-b7da-4e424b2d6c941
198145prednisone 10 MG Oral TabletSCD8e911f16-3db5-4f7e-b7da-4e424b2d6c941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5656-05009056560010 TABLET in 1 BOTTLE (50090-5656-0) 10 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-15009056560115 TABLET in 1 BOTTLE (50090-5656-1) 15 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-25009056560221 TABLET in 1 BOTTLE (50090-5656-2) 21 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-45009056560450 TABLET in 1 BOTTLE (50090-5656-4) 50 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-55009056560530 TABLET in 1 BOTTLE (50090-5656-5) 30 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-750090565607100 TABLET in 1 BOTTLE (50090-5656-7) 100 tablet2021-09-140000-00-00NoNoCurrent
50090-5656-85009056560840 TABLET in 1 BOTTLE (50090-5656-8) 40 tablet2021-09-140000-00-00NoNoCurrent