FDA.reportPublic FDA data

Prednisone

Product NDC
53002-3091
11-digit product format
530023091
Labeler code
53002
Product ID
53002-3091_70e5e3a0-d39e-4bbc-9b90-7e5d98b42321
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-3091-12025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-22025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-32025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-42025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-52025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-62025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-72025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-92025-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-12023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-22023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-32023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-42023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-52023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-62023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-72023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-92023-06-07C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-12023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-22023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-32023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-42023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-52023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-62023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-72023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-92023-01-30C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-12020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-22020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-32020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-42020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-52020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-62020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-72020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-92020-12-15C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-12020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-22020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-32020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-42020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-52020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-62020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-72020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3091-92020-01-31C16284748780-19d75b9d0-1d3b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3091-1Prednisone9 in 1 BOTTLETABLET95
53002-3091-2Prednisone12 in 1 BOTTLETABLET125
53002-3091-3Prednisone14 in 1 BOTTLETABLET145
53002-3091-4Prednisone15 in 1 BOTTLETABLET155
53002-3091-5Prednisone16 in 1 BOTTLETABLET165
53002-3091-6Prednisone18 in 1 BOTTLETABLET185
53002-3091-7Prednisone40 in 1 BOTTLETABLET405
53002-3091-9Prednisone60 in 1 BOTTLETABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3091PREDNISONE (PREDNISONE) TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 8 package rows20230609_b23529ee-eba3-4594-a53d-3000b4493db4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNb23529ee-eba3-4594-a53d-3000b4493db45
198145prednisone 10 MG Oral TabletSCDb23529ee-eba3-4594-a53d-3000b4493db45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3091-1530023091019 TABLET in 1 BOTTLE (53002-3091-1) 9 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-25300230910212 TABLET in 1 BOTTLE (53002-3091-2) 12 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-35300230910314 TABLET in 1 BOTTLE (53002-3091-3) 14 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-45300230910415 TABLET in 1 BOTTLE (53002-3091-4) 15 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-55300230910516 TABLET in 1 BOTTLE (53002-3091-5) 16 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-65300230910618 TABLET in 1 BOTTLE (53002-3091-6) 18 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-75300230910740 TABLET in 1 BOTTLE (53002-3091-7) 40 tablet2018-10-010000-00-00NoNoCurrent
53002-3091-95300230910960 TABLET in 1 BOTTLE (53002-3091-9) 60 tablet2018-10-010000-00-00NoNoCurrent