FDA.reportPublic FDA data

prednisone

Product NDC
70518-3539
11-digit product format
705183539
Labeler code
70518
Product ID
70518-3539_4f574382-e208-ab80-e063-6294a90a70a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-09-26
Substance
PREDNISONE
Active strength
5 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
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
70518-3539-0prednisone30 in 1 BLISTER PACKTABLET3011
70518-3539-1prednisone30 in 1 BLISTER PACKTABLET3011
70518-3539-2prednisone180 in 1 BOTTLE, PLASTICTABLET18011
70518-3539-3prednisone21 in 1 BOTTLE, PLASTICTABLET2111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3539PREDNISONE TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 4 package rows20250507_e9a74862-6a3b-4247-837a-389761b5c352.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNe9a74862-6a3b-4247-837a-389761b5c35211
312617prednisone 5 MG Oral TabletSCDe9a74862-6a3b-4247-837a-389761b5c35211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3539-07051835390030 TABLET in 1 BLISTER PACK (70518-3539-0) 30 tablet2022-09-260000-00-00NoNoCurrent
70518-3539-17051835390130 TABLET in 1 BLISTER PACK (70518-3539-1) 30 tablet2025-01-22NoNoHistorical
70518-3539-270518353902180 TABLET in 1 BOTTLE, PLASTIC (70518-3539-2) 180 tablet2025-02-06NoNoHistorical
70518-3539-37051835390321 TABLET in 1 BOTTLE, PLASTIC (70518-3539-3) 21 tablet2025-10-15NoNoHistorical