FDA.reportPublic FDA data

prednisone

Product NDC
68788-8579
11-digit product format
687888579
Labeler code
68788
Product ID
68788-8579_75ceea22-6217-4d0a-bdc9-bd304f72734d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209727
Marketing category
ANDA
Marketing start
2024-02-02
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8579-3prednisone30 in 1 BOTTLE, PLASTICTABLET302
68788-8579-8prednisone21 in 1 BOTTLE, PLASTICTABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8579-3EA - Each68788-8579926669a0-0ae2-4913-b88d-b36897cb1a3712024-05-16
68788-8579-8EA - Each68788-8579ceeca70d-321f-46d8-850f-4e68549cc55012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8579PREDNISONE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240306_fa75f5ce-8a74-4873-811f-7d9d9beec08f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNfa75f5ce-8a74-4873-811f-7d9d9beec08f2
312617prednisone 5 MG Oral TabletSCDfa75f5ce-8a74-4873-811f-7d9d9beec08f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8579-36878885790330 TABLET in 1 BOTTLE, PLASTIC (68788-8579-3) 30 tablet2024-02-02NoNoHistorical
68788-8579-86878885790821 TABLET in 1 BOTTLE, PLASTIC (68788-8579-8) 21 tablet2024-02-02NoNoHistorical