FDA.reportPublic FDA data

Prednisone

Product NDC
50090-0439
11-digit product format
500900439
Labeler code
50090
Product ID
50090-0439_7412bca0-c3e9-4b3e-917b-77370c78efad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
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, 763181

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
50090-0439-02023-02-07C16284748780-1f386c649-c60b-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
50090-0439-02023-01-30C16284748780-1f386c649-c60b-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0439-0Prednisone21 in 1 BOX, UNIT-DOSETABLET2117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0439-0EA - Each50090-0439c48c0ddd-c209-4106-b798-ec6890ff8edf12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0439PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 1 package rows20230404_71295010-5adb-499b-a03a-5c78b5e79b2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCK71295010-5adb-499b-a03a-5c78b5e79b2d17
312617predniSONE 5 MG Oral TabletPSN71295010-5adb-499b-a03a-5c78b5e79b2d17
763181predniSONE 5 MG Tablet 21 Count PackPSN71295010-5adb-499b-a03a-5c78b5e79b2d17
312617prednisone 5 MG Oral TabletSCD71295010-5adb-499b-a03a-5c78b5e79b2d17
763181Prednisone 5 MG Oral Tablet 21 Count PackSY71295010-5adb-499b-a03a-5c78b5e79b2d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0439-05009004390021 TABLET in 1 BOX, UNIT-DOSE (50090-0439-0) 21 tablet2016-06-290000-00-00NoNoCurrent