FDA.reportPublic FDA data

prednisone

Product NDC
71335-2134
11-digit product format
713352134
Labeler code
71335
Product ID
71335-2134_5a830fcf-56f9-4328-8a87-82ddc72e8763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2026-12-31

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
71335-2134-0prednisone42 in 1 BOTTLETABLET42104
71335-2134-1prednisone30 in 1 BOTTLETABLET30104
71335-2134-2prednisone78 in 1 BOTTLETABLET78104
71335-2134-3prednisone36 in 1 BOTTLETABLET36104
71335-2134-4prednisone21 in 1 BOTTLETABLET21104
71335-2134-5prednisone15 in 1 BOTTLETABLET15104
71335-2134-6prednisone100 in 1 BOTTLETABLET100104
71335-2134-7prednisone20 in 1 BOTTLETABLET20104
71335-2134-8prednisone10 in 1 BOTTLETABLET10104
71335-2134-9prednisone90 in 1 BOTTLETABLET90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2134-1EA - Each71335-21345c33f230-3f44-4f56-be84-f1eafa79d75512025-03-04
71335-2134-6EA - Each71335-213429ba46a0-26e4-438e-9006-71664dc31c0512026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2134PREDNISONE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20250227_f0354431-4968-4e34-969b-6985d73700a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNf0354431-4968-4e34-969b-6985d73700a4104
312617prednisone 5 MG Oral TabletSCDf0354431-4968-4e34-969b-6985d73700a4104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2134-07133521340042 TABLET in 1 BOTTLE (71335-2134-0) 42 tablet2023-03-200000-00-00NoNoCurrent
71335-2134-17133521340130 TABLET in 1 BOTTLE (71335-2134-1) 30 tablet2022-07-210000-00-00NoNoCurrent
71335-2134-27133521340278 TABLET in 1 BOTTLE (71335-2134-2) 78 tablet2025-02-250000-00-00NoNoCurrent
71335-2134-37133521340336 TABLET in 1 BOTTLE (71335-2134-3) 36 tablet2025-02-250000-00-00NoNoCurrent
71335-2134-47133521340421 TABLET in 1 BOTTLE (71335-2134-4) 21 tablet2022-07-260000-00-00NoNoCurrent
71335-2134-57133521340515 TABLET in 1 BOTTLE (71335-2134-5) 15 tablet2023-03-150000-00-00NoNoCurrent
71335-2134-671335213406100 TABLET in 1 BOTTLE (71335-2134-6) 100 tablet2023-02-200000-00-00NoNoCurrent
71335-2134-77133521340720 TABLET in 1 BOTTLE (71335-2134-7) 20 tablet2024-06-040000-00-00NoNoCurrent
71335-2134-87133521340810 TABLET in 1 BOTTLE (71335-2134-8) 10 tablet2023-04-120000-00-00NoNoCurrent
71335-2134-97133521340990 TABLET in 1 BOTTLE (71335-2134-9) 90 tablet2022-07-110000-00-00NoNoCurrent