FDA.reportPublic FDA data

prednisone

Product NDC
71335-2122
11-digit product format
713352122
Labeler code
71335
Product ID
71335-2122_ca3596eb-33bf-4546-8f4e-4f3b927697c9
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
10 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
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
71335-2122-0prednisone12 in 1 BOTTLETABLET12104
71335-2122-1prednisone5 in 1 BOTTLETABLET5104
71335-2122-2prednisone54 in 1 BOTTLETABLET54104
71335-2122-3prednisone90 in 1 BOTTLETABLET90104
71335-2122-4prednisone18 in 1 BOTTLETABLET18104
71335-2122-5prednisone25 in 1 BOTTLETABLET25104
71335-2122-6prednisone26 in 1 BOTTLETABLET26104
71335-2122-7prednisone100 in 1 BOTTLETABLET100104
71335-2122-8prednisone24 in 1 BOTTLETABLET24104
71335-2122-9prednisone16 in 1 BOTTLETABLET16104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2122PREDNISONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20250330_ecc48869-3812-4440-a398-749b28062059.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNecc48869-3812-4440-a398-749b28062059105
198145prednisone 10 MG Oral TabletSCDecc48869-3812-4440-a398-749b28062059105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2122-07133521220012 TABLET in 1 BOTTLE (71335-2122-0) 12 tablet2024-04-03NoNoCurrent
71335-2122-1713352122015 TABLET in 1 BOTTLE (71335-2122-1) 5 tablet2024-04-030000-00-00NoNoCurrent
71335-2122-27133521220254 TABLET in 1 BOTTLE (71335-2122-2) 54 tablet2022-06-170000-00-00NoNoCurrent
71335-2122-37133521220390 TABLET in 1 BOTTLE (71335-2122-3) 90 tablet2024-04-030000-00-00NoNoCurrent
71335-2122-47133521220418 TABLET in 1 BOTTLE (71335-2122-4) 18 tablet2024-04-03NoNoCurrent
71335-2122-57133521220525 TABLET in 1 BOTTLE (71335-2122-5) 25 tablet2024-04-03NoNoCurrent
71335-2122-67133521220626 TABLET in 1 BOTTLE (71335-2122-6) 26 tablet2024-04-03NoNoCurrent
71335-2122-771335212207100 TABLET in 1 BOTTLE (71335-2122-7) 100 tablet2024-04-03NoNoCurrent
71335-2122-87133521220824 TABLET in 1 BOTTLE (71335-2122-8) 24 tablet2024-04-03NoNoCurrent
71335-2122-97133521220916 TABLET in 1 BOTTLE (71335-2122-9) 16 tablet2024-04-03NoNoCurrent