FDA.reportPublic FDA data

prednisone

Product NDC
50090-5814
11-digit product format
500905814
Labeler code
50090
Product ID
50090-5814_96102e8c-8b9e-445e-a364-5d1e36f15780
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209727
Marketing category
ANDA
Marketing start
2021-09-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5814-02023-02-07C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-12023-02-07C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-32023-02-07C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-42023-02-07C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-72023-02-07C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-02023-01-30C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-12023-01-30C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-32023-01-30C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-42023-01-30C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only
50090-5814-72023-01-30C16284748780-1f386c649-d72f-0266-e053-dadaa90a7c1aPredniSONE Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5814-0prednisone21 in 1 BOTTLETABLET216
50090-5814-1prednisone50 in 1 BOTTLETABLET506
50090-5814-3prednisone100 in 1 BOTTLETABLET1006
50090-5814-4prednisone30 in 1 BOTTLETABLET306
50090-5814-7prednisone60 in 1 BOTTLETABLET606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5814-0EA - Each50090-58147bea1d87-a9cc-4576-a92f-a662ac36cc5812022-03-09
50090-5814-1EA - Each50090-5814a184d731-f6e2-4b19-a3a1-91c688711a8012022-03-09
50090-5814-3EA - Each50090-58141697c953-7b49-4dc0-b5cf-c05644b44a6c12022-03-09
50090-5814-4EA - Each50090-5814e26400f3-f6c3-41f6-8476-7ee0eed9a53f12022-03-09
50090-5814-7EA - Each50090-581453e8ae08-6348-4661-99ad-43562337fbef12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5814PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 5 package rows20231125_17278e0a-cbff-4a95-96ee-f34f7466faa0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN17278e0a-cbff-4a95-96ee-f34f7466faa06
312617prednisone 5 MG Oral TabletSCD17278e0a-cbff-4a95-96ee-f34f7466faa06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5814-05009058140021 TABLET in 1 BOTTLE (50090-5814-0) 21 tablet2021-10-180000-00-00NoNoCurrent
50090-5814-15009058140150 TABLET in 1 BOTTLE (50090-5814-1) 50 tablet2021-10-180000-00-00NoNoCurrent
50090-5814-350090581403100 TABLET in 1 BOTTLE (50090-5814-3) 100 tablet2021-10-180000-00-00NoNoCurrent
50090-5814-45009058140430 TABLET in 1 BOTTLE (50090-5814-4) 30 tablet2021-10-180000-00-00NoNoCurrent
50090-5814-75009058140760 TABLET in 1 BOTTLE (50090-5814-7) 60 tablet2021-10-180000-00-00NoNoCurrent