FDA.reportPublic FDA data

prednisone

Product NDC
70518-3401
11-digit product format
705183401
Labeler code
70518
Product ID
70518-3401_4ef6c162-d046-d4f1-e063-6394a90a5ebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-04-05
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
Rxcui312615

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
70518-3401-0prednisone34 in 1 BOTTLE, PLASTICTABLET3417
70518-3401-1prednisone13 in 1 BOTTLE, PLASTICTABLET1317
70518-3401-2prednisone20 in 1 BOTTLE, PLASTICTABLET2017
70518-3401-3prednisone10 in 1 BOTTLE, PLASTICTABLET1017
70518-3401-4prednisone10 in 1 BLISTER PACKTABLET1017
70518-3401-5prednisone15 in 1 BOTTLE, PLASTICTABLET1517
70518-3401-6prednisone30 in 1 BOTTLE, PLASTICTABLET3017
70518-3401-7prednisone20 in 1 BOTTLE, PLASTICTABLET2017
70518-3401-8prednisone10 in 1 BOTTLE, PLASTICTABLET1017
70518-3401-9prednisone14 in 1 BOTTLE, PLASTICTABLET1417

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3401PREDNISONE TABLET [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 10 package rows20250104_af5d0f73-2aef-4db1-ae25-6d465c9f0ca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNaf5d0f73-2aef-4db1-ae25-6d465c9f0ca117
312615prednisone 20 MG Oral TabletSCDaf5d0f73-2aef-4db1-ae25-6d465c9f0ca117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3401-07051834010034 TABLET in 1 BOTTLE, PLASTIC (70518-3401-0) 34 tablet2022-04-050000-00-00NoNoCurrent
70518-3401-17051834010113 TABLET in 1 BOTTLE, PLASTIC (70518-3401-1) 13 tablet2022-04-050000-00-00NoNoCurrent
70518-3401-27051834010220 TABLET in 1 BOTTLE, PLASTIC (70518-3401-2) 20 tablet2022-08-090000-00-00NoNoCurrent
70518-3401-37051834010310 in 1 BOTTLE, PLASTICHistorical
70518-3401-47051834010410 in 1 BLISTER PACKHistorical
70518-3401-57051834010515 in 1 BOTTLE, PLASTICHistorical
70518-3401-67051834010630 in 1 BOTTLE, PLASTICHistorical
70518-3401-77051834010720 in 1 BOTTLE, PLASTICHistorical
70518-3401-87051834010810 TABLET in 1 BOTTLE, PLASTIC (70518-3401-8) 10 tablet2023-11-10NoNoHistorical
70518-3401-97051834010914 TABLET in 1 BOTTLE, PLASTIC (70518-3401-9) 14 tablet2023-11-10NoNoHistorical