FDA.reportPublic FDA data

prednisone

Product NDC
68788-8166
11-digit product format
687888166
Labeler code
68788
Product ID
68788-8166_bc7bf8eb-22cf-4b98-a867-8ff29bcb671e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-04-08
Substance
PREDNISONE
Active strength
10 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
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145

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
68788-8166-1prednisone10 in 1 BOTTLETABLET104
68788-8166-2prednisone21 in 1 BOTTLETABLET214
68788-8166-3prednisone30 in 1 BOTTLETABLET304
68788-8166-4prednisone40 in 1 BOTTLETABLET404
68788-8166-5prednisone50 in 1 BOTTLETABLET504
68788-8166-6prednisone15 in 1 BOTTLETABLET154
68788-8166-7prednisone45 in 1 BOTTLETABLET454
68788-8166-8prednisone20 in 1 BOTTLETABLET204
68788-8166-9prednisone90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8166-2EA - Each68788-81662020bcf0-d766-4da1-a20b-e38f0202ad6412022-05-04
68788-8166-3EA - Each68788-81669b366ff2-474b-4909-b444-fbdf7562d2ce12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8166PREDNISONE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 9 package rows20240802_ce7663a7-4c91-4790-aa43-96f259b3bb18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNce7663a7-4c91-4790-aa43-96f259b3bb184
198145prednisone 10 MG Oral TabletSCDce7663a7-4c91-4790-aa43-96f259b3bb184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8166-16878881660110 TABLET in 1 BOTTLE (68788-8166-1) 10 tablet2023-09-11NoNoCurrent
68788-8166-26878881660221 TABLET in 1 BOTTLE (68788-8166-2) 21 tablet2022-04-080000-00-00NoNoCurrent
68788-8166-36878881660330 TABLET in 1 BOTTLE (68788-8166-3) 30 tablet2022-04-080000-00-00NoNoCurrent
68788-8166-46878881660440 TABLET in 1 BOTTLE (68788-8166-4) 40 tablet2023-09-11NoNoCurrent
68788-8166-56878881660550 TABLET in 1 BOTTLE (68788-8166-5) 50 tablet2023-09-11NoNoCurrent
68788-8166-66878881660615 TABLET in 1 BOTTLE (68788-8166-6) 15 tablet2023-09-11NoNoCurrent
68788-8166-76878881660745 TABLET in 1 BOTTLE (68788-8166-7) 45 tablet2023-09-11NoNoCurrent
68788-8166-86878881660820 TABLET in 1 BOTTLE (68788-8166-8) 20 tablet2023-09-11NoNoCurrent
68788-8166-96878881660990 TABLET in 1 BOTTLE (68788-8166-9) 90 tablet2023-09-11NoNoCurrent