FDA.reportPublic FDA data

Prednisone

Product NDC
50090-2804
11-digit product format
500902804
Labeler code
50090
Product ID
50090-2804_7bab9436-671b-4afb-8c54-7e61f65eabb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA085161
Marketing category
ANDA
Marketing start
1990-01-01
Substance
PREDNISONE
Active strength
20 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
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 312615, 312617

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
50090-2804-0Prednisone20 in 1 BOTTLETABLET2036
50090-2804-1Prednisone12 in 1 BOTTLETABLET1236
50090-2804-2Prednisone6 in 1 BOTTLETABLET636
50090-2804-5Prednisone14 in 1 BOTTLETABLET1436
50090-2804-7Prednisone15 in 1 BOTTLETABLET1536

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2804-0EA - Each50090-280437432656-8060-4e8e-b19a-1a4811e8228112018-11-06
50090-2804-1EA - Each50090-28044dfd3d43-2cd1-4bd4-9045-f9c04f74b14d12019-05-02
50090-2804-2EA - Each50090-28049f623169-cce8-4289-8038-a8f4ab84251d12019-05-02
50090-2804-5EA - Each50090-280479201e66-89ae-4eed-8f52-0f93c75b1cd812019-05-02
50090-2804-7EA - Each50090-280463cabfda-9b01-4212-97c3-f236f69f081c12019-05-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
312615predniSONE 20 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
312617predniSONE 5 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
198145prednisone 10 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36
312615prednisone 20 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36
312617prednisone 5 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-2804-05009028040020 TABLET in 1 BOTTLE (50090-2804-0) 20 tablet2017-01-20NoNoHistorical
50090-2804-15009028040112 in 1 BOTTLEHistorical
50090-2804-2500902804026 TABLET in 1 BOTTLE (50090-2804-2) 6 tablet2018-05-09NoNoHistorical
50090-2804-55009028040514 TABLET in 1 BOTTLE (50090-2804-5) 14 tablet2017-10-18NoNoHistorical
50090-2804-75009028040715 TABLET in 1 BOTTLE (50090-2804-7) 15 tablet2017-10-13NoNoHistorical