FDA.reportPublic FDA data

prednisone

Product NDC
71335-9715
11-digit product format
713359715
Labeler code
71335
Product ID
71335-9715_972bfbf2-e4ff-4fe8-89fb-8ede846dee9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-05-24
Substance
PREDNISONE
Active strength
50 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
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198148

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
71335-9715-1prednisone90 in 1 BOTTLETABLET90103
71335-9715-2prednisone5 in 1 BOTTLETABLET5103
71335-9715-3prednisone30 in 1 BOTTLETABLET30103
71335-9715-4prednisone60 in 1 BOTTLETABLET60103
71335-9715-5prednisone120 in 1 BOTTLETABLET120103
71335-9715-6prednisone7 in 1 BOTTLETABLET7103
71335-9715-7prednisone20 in 1 BOTTLETABLET20103
71335-9715-8prednisone10 in 1 BOTTLETABLET10103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9715-2EA - Each71335-97155dfcf97a-916d-411c-9334-3cc5c9e80a1612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9715PREDNISONE TABLET [BRYANT RANCH PREPACK]102Current NDC, 8 package rows20240830_70d05ed7-5c4e-4cd1-84cd-0dbe90692c54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSN70d05ed7-5c4e-4cd1-84cd-0dbe90692c54103
198148prednisone 50 MG Oral TabletSCD70d05ed7-5c4e-4cd1-84cd-0dbe90692c54103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9715-17133597150190 TABLET in 1 BOTTLE (71335-9715-1) 90 tablet2023-06-08NoNoHistorical
71335-9715-2713359715025 TABLET in 1 BOTTLE (71335-9715-2) 5 tablet2023-05-17NoNoHistorical
71335-9715-37133597150330 TABLET in 1 BOTTLE (71335-9715-3) 30 tablet2023-06-23NoNoHistorical
71335-9715-47133597150460 TABLET in 1 BOTTLE (71335-9715-4) 60 tablet2026-04-09NoNoHistorical
71335-9715-571335971505120 TABLET in 1 BOTTLE (71335-9715-5) 120 tablet2026-04-09NoNoHistorical
71335-9715-6713359715067 TABLET in 1 BOTTLE (71335-9715-6) 7 tablet2026-04-09NoNoHistorical
71335-9715-77133597150720 TABLET in 1 BOTTLE (71335-9715-7) 20 tablet2023-07-25NoNoHistorical
71335-9715-87133597150810 TABLET in 1 BOTTLE (71335-9715-8) 10 tablet2026-04-09NoNoHistorical