FDA.reportPublic FDA data

prednisone

Product NDC
70518-3476
11-digit product format
705183476
Labeler code
70518
Product ID
70518-3476_4f1b5262-b3f4-0488-e063-6294a90a12c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-08-16
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

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
70518-3476-0prednisone21 in 1 BLISTER PACKTABLET2118
70518-3476-1prednisone30 in 1 BLISTER PACKTABLET3018
70518-3476-2prednisone30 in 1 BOTTLE, PLASTICTABLET3018
70518-3476-3prednisone30 in 1 BOTTLE, PLASTICTABLET3018
70518-3476-4prednisone40 in 1 BOTTLE, PLASTICTABLET4018
70518-3476-5prednisone10 in 1 BOTTLE, PLASTICTABLET1018
70518-3476-6prednisone14 in 1 BOTTLE, PLASTICTABLET1418
70518-3476-7prednisone20 in 1 BOTTLE, PLASTICTABLET2018
70518-3476-8prednisone35 in 1 BOTTLE, PLASTICTABLET3518
70518-3476-9prednisone40 in 1 BOTTLE, PLASTICTABLET4018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3476PREDNISONE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 10 package rows20241006_5218e88b-468b-4d60-ab7e-78cca632b23a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN5218e88b-468b-4d60-ab7e-78cca632b23a18
198145prednisone 10 MG Oral TabletSCD5218e88b-468b-4d60-ab7e-78cca632b23a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3476-07051834760021 TABLET in 1 BLISTER PACK (70518-3476-0) 21 tablet2022-08-160000-00-00NoNoCurrent
70518-3476-17051834760130 TABLET in 1 BLISTER PACK (70518-3476-1) 30 tablet2022-09-120000-00-00NoNoCurrent
70518-3476-27051834760230 TABLET in 1 BOTTLE, PLASTIC (70518-3476-2) 30 tablet2022-10-180000-00-00NoNoCurrent
70518-3476-37051834760330 in 1 BOTTLE, PLASTICHistorical
70518-3476-47051834760440 in 1 BOTTLE, PLASTICHistorical
70518-3476-57051834760510 TABLET in 1 BOTTLE, PLASTIC (70518-3476-5) 10 tablet2023-08-18NoNoHistorical
70518-3476-67051834760614 in 1 BOTTLE, PLASTICHistorical
70518-3476-77051834760720 TABLET in 1 BOTTLE, PLASTIC (70518-3476-7) 20 tablet2023-12-08NoNoHistorical
70518-3476-87051834760835 in 1 BOTTLE, PLASTICHistorical
70518-3476-97051834760940 in 1 BOTTLE, PLASTICHistorical