FDA.reportPublic FDA data

Prednisone

Product NDC
71335-0335
11-digit product format
713350335
Labeler code
71335
Product ID
71335-0335_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
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, 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
71335-0335-0Prednisone10 in 1 BOTTLETABLET1015
71335-0335-1Prednisone21 in 1 BOTTLETABLET2115
71335-0335-2Prednisone40 in 1 BOTTLETABLET4015
71335-0335-3Prednisone30 in 1 BOTTLETABLET3015
71335-0335-4Prednisone20 in 1 BOTTLETABLET2015
71335-0335-5Prednisone15 in 1 BOTTLETABLET1515
71335-0335-6Prednisone50 in 1 BOTTLETABLET5015
71335-0335-7Prednisone60 in 1 BOTTLETABLET6015
71335-0335-8Prednisone42 in 1 BOTTLETABLET4215
71335-0335-9Prednisone48 in 1 BOTTLETABLET4815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0335-0EA - Each71335-033594e65d91-8946-495e-a4ac-824867a17fa812018-03-08
71335-0335-1EA - Each71335-03359b37f2a5-0118-45cb-981a-a37cfd9674cc12018-03-08
71335-0335-2EA - Each71335-0335f06cc6a4-783c-4b4d-9cc4-3e91910fc2a212018-03-08
71335-0335-3EA - Each71335-03358c1c9a05-f4ef-4a15-b78b-385ac90259c712018-03-08
71335-0335-4EA - Each71335-0335c4dc81f6-8ace-4df2-9a56-e2cbf70ede8012018-03-08
71335-0335-5EA - Each71335-033536a5e77c-82b5-4e1c-89c5-077a7e3097c412018-03-08
71335-0335-6EA - Each71335-03358856fc69-5af5-4ce2-b121-4e2351973c0a12018-03-08
71335-0335-7EA - Each71335-0335364d0fc7-0eb8-40b5-b340-a23176bab1b512018-03-08
71335-0335-8EA - Each71335-033584c5a8d3-ca33-4954-93ee-350825b181f312018-03-08
71335-0335-9EA - Each71335-03358fa6f54f-a522-4479-87ba-66410dd9863812018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0335PREDNISONE (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
71335-0335-07133503350010 TABLET in 1 BOTTLE (71335-0335-0) 10 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-17133503350121 TABLET in 1 BOTTLE (71335-0335-1) 21 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-27133503350240 TABLET in 1 BOTTLE (71335-0335-2) 40 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-37133503350330 TABLET in 1 BOTTLE (71335-0335-3) 30 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-47133503350420 TABLET in 1 BOTTLE (71335-0335-4) 20 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-57133503350515 TABLET in 1 BOTTLE (71335-0335-5) 15 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-67133503350650 TABLET in 1 BOTTLE (71335-0335-6) 50 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-77133503350760 TABLET in 1 BOTTLE (71335-0335-7) 60 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-87133503350842 TABLET in 1 BOTTLE (71335-0335-8) 42 tablet2010-10-260000-00-00NoNoCurrent
71335-0335-97133503350948 TABLET in 1 BOTTLE (71335-0335-9) 48 tablet2010-10-260000-00-00NoNoCurrent