FDA.reportPublic FDA data

PREDNISONE

Product NDC
50090-4784
11-digit product format
500904784
Labeler code
50090
Product ID
50090-4784_b61a79e7-5916-4f25-b265-b110044c4c0f
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
20 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
50090-4784-12023-01-30C16284748780-1f386c649-f131-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-4784-22023-01-30C16284748780-1f386c649-f131-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-4784-32023-01-30C16284748780-1f386c649-f131-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-4784-52023-01-30C16284748780-1f386c649-f131-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
50090-4784-92023-01-30C16284748780-1f386c649-f131-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4784-1PREDNISONE10 in 1 BOTTLETABLET104
50090-4784-2PREDNISONE21 in 1 BOTTLETABLET214
50090-4784-3PREDNISONE30 in 1 BOTTLETABLET304
50090-4784-5PREDNISONE100 in 1 BOTTLETABLET1004
50090-4784-9PREDNISONE18 in 1 BOTTLETABLET184

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4784-1EA - Each50090-4784b1d422f3-87c6-4391-914c-4cf42f556bb712022-01-06
50090-4784-3EA - Each50090-4784a25f0175-981a-4d55-9e45-8d281c0fc50512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4784PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]4Legacy NDC, 5 package rows20210918_9e0cbcbe-b0a9-4663-8e71-4bee419da8ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN9e0cbcbe-b0a9-4663-8e71-4bee419da8ae4
312615prednisone 20 MG Oral TabletSCD9e0cbcbe-b0a9-4663-8e71-4bee419da8ae4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4784-15009047840110 TABLET in 1 BOTTLE (50090-4784-1) 10 tablet2019-12-100000-00-00NoNoCurrent
50090-4784-25009047840221 TABLET in 1 BOTTLE (50090-4784-2) 21 tablet2019-12-100000-00-00NoNoCurrent
50090-4784-35009047840330 TABLET in 1 BOTTLE (50090-4784-3) 30 tablet2019-12-100000-00-00NoNoCurrent
50090-4784-550090478405100 TABLET in 1 BOTTLE (50090-4784-5) 100 tablet2019-12-100000-00-00NoNoCurrent
50090-4784-95009047840918 TABLET in 1 BOTTLE (50090-4784-9) 18 tablet2019-12-100000-00-00NoNoCurrent