FDA.reportPublic FDA data

prednisone

Product NDC
85766-001
11-digit product format
857660001
Labeler code
85766
Product ID
85766-001_49ee743e-9fb2-fcb7-e063-6294a90aeefd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
10 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
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 312615

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
85766-001-00prednisone1000 in 1 BOTTLE, PLASTICTABLET10003
85766-001-01prednisone100 in 1 BOTTLE, PLASTICTABLET1003
85766-001-05prednisone500 in 1 BOTTLE, PLASTICTABLET5003
85766-001-18prednisone18 in 1 BOTTLE, PLASTICTABLET183
85766-001-20prednisone20 in 1 BOTTLE, PLASTICTABLET203
85766-001-30prednisone30 in 1 BOTTLE, PLASTICTABLET303
85766-001-60prednisone60 in 1 BOTTLE, PLASTICTABLET603
85766-001-90prednisone90 in 1 BOTTLE, PLASTICTABLET903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615predniSONE 20 MG Oral TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
198145prednisone 10 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615prednisone 20 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-001-00857660001001000 TABLET in 1 BOTTLE, PLASTIC (85766-001-00) 1000 tablet2025-06-19NoNoHistorical
85766-001-0185766000101100 TABLET in 1 BOTTLE, PLASTIC (85766-001-01) 100 tablet2025-06-19NoNoHistorical
85766-001-0585766000105500 TABLET in 1 BOTTLE, PLASTIC (85766-001-05) 500 tablet2025-06-19NoNoHistorical
85766-001-188576600011818 TABLET in 1 BOTTLE, PLASTIC (85766-001-18) 18 tablet2025-06-19NoNoHistorical
85766-001-208576600012020 TABLET in 1 BOTTLE, PLASTIC (85766-001-20) 20 tablet2025-06-19NoNoHistorical
85766-001-308576600013030 TABLET in 1 BOTTLE, PLASTIC (85766-001-30) 30 tablet2025-06-19NoNoHistorical
85766-001-608576600016060 TABLET in 1 BOTTLE, PLASTIC (85766-001-60) 60 tablet2025-06-19NoNoHistorical
85766-001-908576600019090 TABLET in 1 BOTTLE, PLASTIC (85766-001-90) 90 tablet2025-06-19NoNoHistorical