FDA.reportPublic FDA data

Prednisone

Product NDC
71335-0623
11-digit product format
713350623
Labeler code
71335
Product ID
71335-0623_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
20 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
PREDNISONE20 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
71335-0623-0Prednisone11 in 1 BOTTLETABLET1115
71335-0623-1Prednisone20 in 1 BOTTLETABLET2015
71335-0623-2Prednisone30 in 1 BOTTLETABLET3015
71335-0623-3Prednisone40 in 1 BOTTLETABLET4015
71335-0623-4Prednisone15 in 1 BOTTLETABLET1515
71335-0623-5Prednisone10 in 1 BOTTLETABLET1015
71335-0623-6Prednisone21 in 1 BOTTLETABLET2115
71335-0623-7Prednisone18 in 1 BOTTLETABLET1815
71335-0623-8Prednisone12 in 1 BOTTLETABLET1215
71335-0623-9Prednisone23 in 1 BOTTLETABLET2315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0623-1EA - Each71335-0623f7f569fc-e2ed-4bee-942c-65b9ede0353e12019-04-11
71335-0623-6EA - Each71335-062343c4d7cd-3d5c-4dad-a327-9cce7ae4a70012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0623PREDNISONE (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
71335-0623-07133506230011 TABLET in 1 BOTTLE (71335-0623-0) 11 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-17133506230120 TABLET in 1 BOTTLE (71335-0623-1) 20 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-27133506230230 TABLET in 1 BOTTLE (71335-0623-2) 30 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-37133506230340 TABLET in 1 BOTTLE (71335-0623-3) 40 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-47133506230415 TABLET in 1 BOTTLE (71335-0623-4) 15 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-57133506230510 TABLET in 1 BOTTLE (71335-0623-5) 10 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-67133506230621 TABLET in 1 BOTTLE (71335-0623-6) 21 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-77133506230718 TABLET in 1 BOTTLE (71335-0623-7) 18 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-87133506230812 TABLET in 1 BOTTLE (71335-0623-8) 12 tablet2015-03-200000-00-00NoNoCurrent
71335-0623-97133506230923 TABLET in 1 BOTTLE (71335-0623-9) 23 tablet2015-03-200000-00-00NoNoCurrent