FDA.reportPublic FDA data

Prednisone

Product NDC
71335-0508
11-digit product format
713350508
Labeler code
71335
Product ID
71335-0508_1d5b8df8-e31d-4c84-ab41-46c718ebb027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
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
Rxcui198145, 312615, 312617

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
71335-0508-0Prednisone42 in 1 BOTTLETABLET4215
71335-0508-1Prednisone30 in 1 BOTTLETABLET3015
71335-0508-2Prednisone78 in 1 BOTTLETABLET7815
71335-0508-3Prednisone36 in 1 BOTTLETABLET3615
71335-0508-4Prednisone21 in 1 BOTTLETABLET2115
71335-0508-5Prednisone15 in 1 BOTTLETABLET1515
71335-0508-6Prednisone100 in 1 BOTTLETABLET10015
71335-0508-7Prednisone20 in 1 BOTTLETABLET2015
71335-0508-8Prednisone10 in 1 BOTTLETABLET1015
71335-0508-9Prednisone90 in 1 BOTTLETABLET9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0508-0EA - Each71335-0508a543f02b-af67-4bbe-8171-8e9fc9dcf3fc12018-03-08
71335-0508-1EA - Each71335-0508cdc39a81-7be2-412d-9089-2156a75efc4012018-03-08
71335-0508-2EA - Each71335-05085a3cc7af-8c2e-4097-a38d-67140cbc845412018-03-08
71335-0508-3EA - Each71335-05083792c138-c8cc-49aa-ba4b-06b3c8519b5512018-03-08
71335-0508-4EA - Each71335-05082a332326-4cad-48fe-9f46-a4916df3b7a612018-03-08
71335-0508-5EA - Each71335-0508d72b0ef1-432f-4651-a502-bd683f652b3512018-03-08
71335-0508-6EA - Each71335-05080fafc72e-0d2e-415c-869a-da6d450aa17d12018-03-08
71335-0508-7EA - Each71335-0508e6843049-598a-44cd-9584-a83368ea0a6012018-03-08
71335-0508-8EA - Each71335-05080d051bd2-790d-43d5-9d21-6aa67a28960012018-03-08
71335-0508-9EA - Each71335-0508b6305a24-38a2-464d-b0b0-930879e7ac0412018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0508PREDNISONE (PREDNISONE) TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 10 package rows20240809_70003b50-1802-436d-9bee-3e2e4858e461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312615predniSONE 20 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312617predniSONE 5 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
198145prednisone 10 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312615prednisone 20 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312617prednisone 5 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0508-07133505080042 TABLET in 1 BOTTLE (71335-0508-0) 42 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-17133505080130 TABLET in 1 BOTTLE (71335-0508-1) 30 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-27133505080278 TABLET in 1 BOTTLE (71335-0508-2) 78 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-37133505080336 TABLET in 1 BOTTLE (71335-0508-3) 36 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-47133505080421 TABLET in 1 BOTTLE (71335-0508-4) 21 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-57133505080515 TABLET in 1 BOTTLE (71335-0508-5) 15 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-671335050806100 TABLET in 1 BOTTLE (71335-0508-6) 100 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-77133505080720 TABLET in 1 BOTTLE (71335-0508-7) 20 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-87133505080810 TABLET in 1 BOTTLE (71335-0508-8) 10 tablet2015-02-190000-00-00NoNoCurrent
71335-0508-97133505080990 TABLET in 1 BOTTLE (71335-0508-9) 90 tablet2015-02-190000-00-00NoNoCurrent