FDA.reportPublic FDA data

prednisone

Product NDC
50090-7684
11-digit product format
500907684
Labeler code
50090
Product ID
50090-7684_4e631e86-7caf-4cad-8d38-f24c5d1d968b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213385
Marketing category
ANDA
Marketing start
2021-08-04
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
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
50090-7684-0prednisone21 in 1 BOTTLETABLET211
50090-7684-1prednisone50 in 1 BOTTLETABLET501
50090-7684-3prednisone100 in 1 BOTTLETABLET1001
50090-7684-4prednisone30 in 1 BOTTLETABLET301
50090-7684-7prednisone60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7684-0EA - Each50090-76842569c5a7-3ea0-4990-ba5f-5c258ae6e89612025-12-16
50090-7684-1EA - Each50090-76844609e006-df35-46a3-aba6-f124080c6ec912025-12-16
50090-7684-3EA - Each50090-76844636c398-2038-4f9c-be8c-60af7ba9cf6312025-12-16
50090-7684-4EA - Each50090-76845267d5c2-fb66-4512-9010-2145b3f1625612025-12-16
50090-7684-7EA - Each50090-768411fb0144-2d15-4967-b2e9-9df9c89ea9e012025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN43a4b2eb-f2cd-410f-9719-577fdc4ad5de1
312617prednisone 5 MG Oral TabletSCD43a4b2eb-f2cd-410f-9719-577fdc4ad5de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7684-05009076840021 TABLET in 1 BOTTLE (50090-7684-0) 21 tablet2025-10-09NoNoCurrent
50090-7684-15009076840150 TABLET in 1 BOTTLE (50090-7684-1) 50 tablet2025-10-09NoNoCurrent
50090-7684-350090768403100 TABLET in 1 BOTTLE (50090-7684-3) 100 tablet2025-10-09NoNoCurrent
50090-7684-45009076840430 TABLET in 1 BOTTLE (50090-7684-4) 30 tablet2025-10-09NoNoCurrent
50090-7684-75009076840760 TABLET in 1 BOTTLE (50090-7684-7) 60 tablet2025-10-09NoNoCurrent