Prednisone

Product NDC
53002-3250
11-digit product format
530023250
Labeler code
53002
Product ID
53002-3250_6bfe85de-2795-4a48-9935-03438e6cae9d
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
20 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
53002-3250-12025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-22025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-32025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-42025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-52025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-62025-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-12023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-22023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-32023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-42023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-52023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-62023-06-07C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-12023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-22023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-32023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-42023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-52023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-62023-01-30C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-12020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-22020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-32020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-42020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-52020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-62020-12-15C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-12020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-22020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-32020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-42020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-52020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53002-3250-62020-01-31C16284748780-19d75b9d0-5e63-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3250-1Prednisone10 in 1 BOTTLETABLET108
53002-3250-2Prednisone15 in 1 BOTTLETABLET158
53002-3250-3Prednisone18 in 1 BOTTLETABLET188
53002-3250-4Prednisone20 in 1 BOTTLETABLET208
53002-3250-5Prednisone21 in 1 BOTTLETABLET218
53002-3250-6Prednisone30 in 1 BOTTLETABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3250PREDNISONE (PREDNISONE) TABLET [RPK PHARMACEUTICALS, INC.]8Legacy NDC, 6 package rows20230609_bcc8c648-fc70-44e8-9acc-cdf893097a38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNbcc8c648-fc70-44e8-9acc-cdf893097a388
312615predniSONE 20 MG Oral TabletPSNbcc8c648-fc70-44e8-9acc-cdf893097a388
198145prednisone 10 MG Oral TabletSCDbcc8c648-fc70-44e8-9acc-cdf893097a388
312615prednisone 20 MG Oral TabletSCDbcc8c648-fc70-44e8-9acc-cdf893097a388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3250-15300232500110 TABLET in 1 BOTTLE (53002-3250-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-3250-25300232500215 TABLET in 1 BOTTLE (53002-3250-2) 15 tablet2017-10-010000-00-00NoNoCurrent
53002-3250-35300232500318 TABLET in 1 BOTTLE (53002-3250-3) 18 tablet2017-10-010000-00-00NoNoCurrent
53002-3250-45300232500420 TABLET in 1 BOTTLE (53002-3250-4) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-3250-55300232500521 TABLET in 1 BOTTLE (53002-3250-5) 21 tablet2017-10-010000-00-00NoNoCurrent
53002-3250-65300232500630 TABLET in 1 BOTTLE (53002-3250-6) 30 tablet2017-10-010000-00-00NoNoCurrent