Prednisone

Product NDC
53217-255
11-digit product format
532170255
Labeler code
53217
Product ID
53217-255_f4a25e15-16e1-4da9-a77b-d3914a067310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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
53217-255-102020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-122020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-142020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-202020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-212020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-242020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-272020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-302020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-402020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-422020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-482020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-502020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-602020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only
53217-255-902020-01-31C16284748780-19d75b9d0-566b-f424-e053-dadaa90a57cePredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-255-10Prednisone10 in 1 BOTTLETABLET103
53217-255-12Prednisone12 in 1 BOTTLETABLET123
53217-255-14Prednisone14 in 1 BOTTLETABLET143
53217-255-20Prednisone20 in 1 BOTTLETABLET203
53217-255-21Prednisone21 in 1 BOTTLETABLET213
53217-255-24Prednisone24 in 1 BOTTLETABLET243
53217-255-27Prednisone27 in 1 BOTTLETABLET273
53217-255-30Prednisone30 in 1 BOTTLETABLET303
53217-255-40Prednisone40 in 1 BOTTLETABLET403
53217-255-42Prednisone42 in 1 BOTTLETABLET423
53217-255-48Prednisone48 in 1 BOTTLETABLET483
53217-255-50Prednisone50 in 1 BOTTLETABLET503
53217-255-60Prednisone60 in 1 BOTTLETABLET603
53217-255-90Prednisone90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-255-10EA - Each53217-255a04fcb57-00a7-4b28-b141-2c0de8121b6212017-04-05
53217-255-12EA - Each53217-255acf8d81f-ce69-4762-a984-a6345549c91b12017-04-05
53217-255-14EA - Each53217-255a68a4f55-f0ae-40ef-b7fc-f6206b1b431912017-04-05
53217-255-20EA - Each53217-255be6acb52-3f85-4d19-a285-f879fca71b4512017-04-05
53217-255-21EA - Each53217-25573cdb6ac-6c52-4ad5-ac7b-46febacf9d4712017-04-05
53217-255-24EA - Each53217-2559361c044-7a12-4c62-bd7d-0fdfcc614efb12017-04-05
53217-255-27EA - Each53217-25504a20530-7f02-4f63-9436-7a63fa02e82212017-04-05
53217-255-30EA - Each53217-255a62d0edb-b365-4f76-9116-4aeaabffc41d12017-04-05
53217-255-40EA - Each53217-25534b8b261-b399-4ca1-9bed-36f60c621fe612017-04-05
53217-255-42EA - Each53217-255ad8ed85b-2f6d-43d4-a2c6-659e7681182912017-04-05
53217-255-48EA - Each53217-2552300a031-4d3e-40e2-b533-0b4f633b18a212017-04-05
53217-255-50EA - Each53217-255dc3fc36e-63b6-4b7d-ba54-4b4cba779b7f12017-04-05
53217-255-60EA - Each53217-25588f45018-fb32-4b4f-b599-39bb0824d44212017-04-05
53217-255-90EA - Each53217-255193eea0d-a46e-454b-bd2e-2e8a8680b6d112017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-255PREDNISONE TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 14 package rows20170331_f2cb8d8b-6ed9-4c21-8830-924832947b2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf2cb8d8b-6ed9-4c21-8830-924832947b2b3
198145prednisone 10 MG Oral TabletSCDf2cb8d8b-6ed9-4c21-8830-924832947b2b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-255-105321702551010 in 1 BOTTLEHistorical
53217-255-125321702551212 in 1 BOTTLEHistorical
53217-255-145321702551414 in 1 BOTTLEHistorical
53217-255-205321702552020 in 1 BOTTLEHistorical
53217-255-215321702552121 in 1 BOTTLEHistorical
53217-255-245321702552424 in 1 BOTTLEHistorical
53217-255-275321702552727 in 1 BOTTLEHistorical
53217-255-305321702553030 in 1 BOTTLEHistorical
53217-255-405321702554040 in 1 BOTTLEHistorical
53217-255-425321702554242 in 1 BOTTLEHistorical
53217-255-485321702554848 in 1 BOTTLEHistorical
53217-255-505321702555050 in 1 BOTTLEHistorical
53217-255-605321702556060 in 1 BOTTLEHistorical
53217-255-905321702559090 in 1 BOTTLEHistorical