FDA.reportPublic FDA data

prednisone

Product NDC
70518-4038
11-digit product format
705184038
Labeler code
70518
Product ID
70518-4038_51b89f74-a606-686e-e063-6294a90a58a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2024-03-15
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
70518-4038-0prednisone48 in 1 BOTTLE, PLASTICTABLET4811
70518-4038-1prednisone15 in 1 BOTTLE, PLASTICTABLET1511
70518-4038-2prednisone18 in 1 BOTTLE, PLASTICTABLET1811
70518-4038-3prednisone10 in 1 BOTTLE, PLASTICTABLET1011
70518-4038-4prednisone30 in 1 BLISTER PACKTABLET3011
70518-4038-5prednisone20 in 1 BOTTLE, PLASTICTABLET2011
70518-4038-6prednisone14 in 1 BOTTLE, PLASTICTABLET1411
70518-4038-7prednisone21 in 1 BOTTLE, PLASTICTABLET2111
70518-4038-8prednisone20 in 1 BOTTLE, PLASTICTABLET2011
70518-4038-9prednisone100 in 1 BOTTLE, PLASTICTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4038PREDNISONE TABLET [REMEDYREPACK INC.]6Current NDC, 10 package rows20250406_b3b70d6f-dc44-4a54-b39b-2762f37d5575.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNb3b70d6f-dc44-4a54-b39b-2762f37d557511
198145prednisone 10 MG Oral TabletSCDb3b70d6f-dc44-4a54-b39b-2762f37d557511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4038-07051840380048 TABLET in 1 BOTTLE, PLASTIC (70518-4038-0) 48 tablet2024-03-15NoNoHistorical
70518-4038-17051840380115 in 1 BOTTLE, PLASTICHistorical
70518-4038-27051840380218 in 1 BOTTLE, PLASTICHistorical
70518-4038-37051840380310 TABLET in 1 BOTTLE, PLASTIC (70518-4038-3) 10 tablet2024-04-16NoNoHistorical
70518-4038-47051840380430 in 1 BLISTER PACKHistorical
70518-4038-57051840380520 TABLET in 1 BOTTLE, PLASTIC (70518-4038-5) 20 tablet2025-03-25NoNoHistorical
70518-4038-67051840380614 TABLET in 1 BOTTLE, PLASTIC (70518-4038-6) 14 tablet2025-04-03NoNoHistorical
70518-4038-77051840380721 TABLET in 1 BOTTLE, PLASTIC (70518-4038-7) 21 tablet2026-02-11NoNoHistorical
70518-4038-87051840380820 TABLET in 1 BOTTLE, PLASTIC (70518-4038-8) 20 tablet2026-04-03NoNoHistorical
70518-4038-970518403809100 TABLET in 1 BOTTLE, PLASTIC (70518-4038-9) 100 tablet2026-05-13NoNoHistorical