FDA.reportPublic FDA data

PREDNISONE

Product NDC
50090-7931
11-digit product format
500907931
Labeler code
50090
Product ID
50090-7931_560225a2-68cd-40b2-8c02-5e477df2720b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
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

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
50090-7931-0PREDNISONE21 in 1 BOTTLETABLET211
50090-7931-1PREDNISONE50 in 1 BOTTLETABLET501
50090-7931-3PREDNISONE100 in 1 BOTTLETABLET1001
50090-7931-4PREDNISONE30 in 1 BOTTLETABLET301
50090-7931-7PREDNISONE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7931-0EA - Each50090-793179a4c9d1-46a2-48cf-81b8-60086f7dc5b312026-04-20
50090-7931-1EA - Each50090-7931ff03ee1a-9c1c-4f54-a52b-0c5b7864c40112026-04-20
50090-7931-3EA - Each50090-79319ec2e42b-a703-483f-969f-014d2b5d6d7112026-04-20
50090-7931-4EA - Each50090-793172e22190-2eab-4e84-9493-cd7f06592f5a12026-04-20
50090-7931-7EA - Each50090-7931b1522aae-ed0c-4b82-8e11-c8dfa294fab912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNe753e2bc-acca-46eb-888c-ae72fcac6ca41
312617prednisone 5 MG Oral TabletSCDe753e2bc-acca-46eb-888c-ae72fcac6ca41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7931-05009079310021 TABLET in 1 BOTTLE (50090-7931-0) 21 tablet2026-03-10NoNoHistorical
50090-7931-15009079310150 TABLET in 1 BOTTLE (50090-7931-1) 50 tablet2026-03-10NoNoHistorical
50090-7931-350090793103100 TABLET in 1 BOTTLE (50090-7931-3) 100 tablet2026-03-10NoNoHistorical
50090-7931-45009079310430 TABLET in 1 BOTTLE (50090-7931-4) 30 tablet2026-03-10NoNoHistorical
50090-7931-75009079310760 TABLET in 1 BOTTLE (50090-7931-7) 60 tablet2026-03-10NoNoHistorical