FDA.reportPublic FDA data

Prednisone

Product NDC
50090-5202
11-digit product format
500905202
Labeler code
50090
Product ID
50090-5202_823a4300-4ca6-4115-a5ef-a0884f9bbca3
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
10 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
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145

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
50090-5202-02023-02-07C16284748780-1f386c649-c355-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
50090-5202-12023-02-07C16284748780-1f386c649-c355-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
50090-5202-02023-01-30C16284748780-1f386c649-c355-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only
50090-5202-12023-01-30C16284748780-1f386c649-c355-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5202-0Prednisone60 in 1 BOTTLETABLET606
50090-5202-1Prednisone20 in 1 BOTTLETABLET206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5202-1EA - Each50090-5202197928e5-266d-4f92-9595-87b78dae168812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5202PREDNISONE (PREDNISONE) TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240604_cb1b0dc0-6916-4e6f-9775-26ea0f593f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNcb1b0dc0-6916-4e6f-9775-26ea0f593f836
198145prednisone 10 MG Oral TabletSCDcb1b0dc0-6916-4e6f-9775-26ea0f593f836

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5202-05009052020060 TABLET in 1 BOTTLE (50090-5202-0) 60 tablet2020-10-020000-00-00NoNoCurrent
50090-5202-15009052020120 TABLET in 1 BOTTLE (50090-5202-1) 20 tablet2020-10-020000-00-00NoNoCurrent