FDA.reportPublic FDA data

prednisone

Product NDC
71335-2069
11-digit product format
713352069
Labeler code
71335
Product ID
71335-2069_7d233ed2-f92f-48f1-bd5a-8bf14eddae42
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
2026-12-31

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
71335-2069-0prednisone10 in 1 BOTTLETABLET10104
71335-2069-1prednisone21 in 1 BOTTLETABLET21104
71335-2069-2prednisone40 in 1 BOTTLETABLET40104
71335-2069-3prednisone30 in 1 BOTTLETABLET30104
71335-2069-4prednisone20 in 1 BOTTLETABLET20104
71335-2069-5prednisone15 in 1 BOTTLETABLET15104
71335-2069-6prednisone50 in 1 BOTTLETABLET50104
71335-2069-7prednisone60 in 1 BOTTLETABLET60104
71335-2069-8prednisone42 in 1 BOTTLETABLET42104
71335-2069-9prednisone48 in 1 BOTTLETABLET48104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2069-1EA - Each71335-20691f48b2c7-040a-49b5-9ebb-f8185795fc7a12023-09-05
71335-2069-3EA - Each71335-20697df7e83b-c4e9-42de-9766-744517bb3e3f12025-08-11
71335-2069-4EA - Each71335-20693010ba4d-f685-44ad-ade8-58c615c8277712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2069PREDNISONE TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240809_a2ba1a31-9e2d-4c1e-9bbd-b813831ce08f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNa2ba1a31-9e2d-4c1e-9bbd-b813831ce08f104
198145prednisone 10 MG Oral TabletSCDa2ba1a31-9e2d-4c1e-9bbd-b813831ce08f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2069-07133520690010 TABLET in 1 BOTTLE (71335-2069-0) 10 tablet2022-05-020000-00-00NoNoCurrent
71335-2069-17133520690121 TABLET in 1 BOTTLE (71335-2069-1) 21 tablet2022-04-110000-00-00NoNoCurrent
71335-2069-27133520690240 TABLET in 1 BOTTLE (71335-2069-2) 40 tablet2022-04-190000-00-00NoNoCurrent
71335-2069-37133520690330 TABLET in 1 BOTTLE (71335-2069-3) 30 tablet2022-03-300000-00-00NoNoCurrent
71335-2069-47133520690420 TABLET in 1 BOTTLE (71335-2069-4) 20 tablet2022-04-290000-00-00NoNoCurrent
71335-2069-57133520690515 TABLET in 1 BOTTLE (71335-2069-5) 15 tablet2022-07-050000-00-00NoNoCurrent
71335-2069-67133520690650 TABLET in 1 BOTTLE (71335-2069-6) 50 tablet2024-04-030000-00-00NoNoCurrent
71335-2069-77133520690760 TABLET in 1 BOTTLE (71335-2069-7) 60 tablet2022-06-010000-00-00NoNoCurrent
71335-2069-87133520690842 TABLET in 1 BOTTLE (71335-2069-8) 42 tablet2022-05-310000-00-00NoNoCurrent
71335-2069-97133520690948 TABLET in 1 BOTTLE (71335-2069-9) 48 tablet2024-04-030000-00-00NoNoCurrent