FDA.reportPublic FDA data

Prednisone

Product NDC
50090-3354
11-digit product format
500903354
Labeler code
50090
Product ID
50090-3354_23a2c0da-a2fa-4d3c-9639-738b749e0242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615, 312617

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3354-0Prednisone21 in 1 BOTTLE, PLASTICTABLET2121
50090-3354-1Prednisone50 in 1 BOTTLETABLET5021
50090-3354-3Prednisone100 in 1 BOTTLETABLET10021
50090-3354-4Prednisone30 in 1 BOTTLE, PLASTICTABLET3021
50090-3354-7Prednisone60 in 1 BOTTLETABLET6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3354-0EA - Each50090-3354c209c36d-139f-46b7-9bf6-d5dcd421b4b912021-09-07
50090-3354-1EA - Each50090-33549a68ea39-402f-4826-9039-6b139ab8548a12019-05-02
50090-3354-3EA - Each50090-335444a2d472-5187-4574-8d09-3441949778e812019-05-02
50090-3354-4EA - Each50090-33547b38a9c4-dd6c-44bd-b48b-46f9a4773bd712021-09-07
50090-3354-7EA - Each50090-335487fa2c01-d9e1-4cba-93d8-d7a74157a63712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3354PREDNISONE (PREDNISONE) TABLET [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 5 package rows20240627_751b7f62-f92b-4b7c-a588-2c882d5d1ce3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312617predniSONE 5 MG Oral TabletPSN751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312615prednisone 20 MG Oral TabletSCD751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312617prednisone 5 MG Oral TabletSCD751b7f62-f92b-4b7c-a588-2c882d5d1ce321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3354-05009033540021 TABLET in 1 BOTTLE, PLASTIC (50090-3354-0) 21 tablet2014-11-280000-00-00NoNoCurrent
50090-3354-15009033540150 TABLET in 1 BOTTLE (50090-3354-1) 50 tablet2018-01-310000-00-00NoNoCurrent
50090-3354-350090335403100 TABLET in 1 BOTTLE (50090-3354-3) 100 tablet2018-02-160000-00-00NoNoCurrent
50090-3354-45009033540430 TABLET in 1 BOTTLE, PLASTIC (50090-3354-4) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-3354-75009033540760 TABLET in 1 BOTTLE (50090-3354-7) 60 tablet2018-01-300000-00-00NoNoCurrent