FDA.reportPublic FDA data

prednisone

Product NDC
70518-3540
11-digit product format
705183540
Labeler code
70518
Product ID
70518-3540_4f586bb6-52ba-eda4-e063-6394a90a446b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213386
Marketing category
ANDA
Marketing start
2022-09-26
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
70518-3540-0prednisone30 in 1 BLISTER PACKTABLET308
70518-3540-1prednisone10 in 1 BOTTLE, PLASTICTABLET108
70518-3540-2prednisone10 in 1 BLISTER PACKTABLET108
70518-3540-3prednisone30 in 1 BLISTER PACKTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3540PREDNISONE TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 4 package rows20250523_e47a0448-331f-4846-8e63-c52c3afa274b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNe47a0448-331f-4846-8e63-c52c3afa274b8
312615prednisone 20 MG Oral TabletSCDe47a0448-331f-4846-8e63-c52c3afa274b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3540-07051835400030 TABLET in 1 BLISTER PACK (70518-3540-0) 30 tablet2022-09-260000-00-00NoNoCurrent
70518-3540-17051835400110 in 1 BOTTLE, PLASTICHistorical
70518-3540-27051835400210 TABLET in 1 BLISTER PACK (70518-3540-2) 10 tablet2025-04-13NoNoCurrent
70518-3540-37051835400330 TABLET in 1 BLISTER PACK (70518-3540-3) 30 tablet2025-05-16NoNoCurrent