FDA.reportPublic FDA data

Prednisone

Product NDC
12634-188
11-digit product format
126340188
Labeler code
12634
Product ID
12634-188_280c9fe8-339a-177a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
1974-02-26
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
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
12634-188-002020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-012020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-522020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-542020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-552020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-572020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-712020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-792020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-802020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-812020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-822020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-842020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-852020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW
12634-188-912020-01-31C16284748780-19d75b9cf-da60-f424-e053-dadaa90a57cePrednisone Tablets - WW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-188-00Prednisone10 in 1 BOTTLETABLET101
12634-188-01Prednisone100 in 1 BOTTLETABLET1001
12634-188-52Prednisone12 in 1 BLISTER PACKTABLET121
12634-188-54Prednisone14 in 1 BLISTER PACKTABLET141
12634-188-55Prednisone15 in 1 BLISTER PACKTABLET151
12634-188-57Prednisone20 in 1 BLISTER PACKTABLET201
12634-188-71Prednisone30 in 1 BOTTLETABLET301
12634-188-79Prednisone25 in 1 BOTTLETABLET251
12634-188-80Prednisone20 in 1 BOTTLETABLET201
12634-188-81Prednisone21 in 1 BOTTLETABLET211
12634-188-82Prednisone12 in 1 BOTTLETABLET121
12634-188-84Prednisone14 in 1 BOTTLETABLET141
12634-188-85Prednisone15 in 1 BOTTLETABLET151
12634-188-91Prednisone1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-188PREDNISONE TABLET [APOTHECA INC.]1Legacy NDC, 14 package rows20151229_280c9fe8-3399-177a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN280c9fe8-3399-177a-e054-00144ff88e881
312615prednisone 20 MG Oral TabletSCD280c9fe8-3399-177a-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-188-001263401880010 in 1 BOTTLEHistorical
12634-188-0112634018801100 in 1 BOTTLEHistorical
12634-188-521263401885212 in 1 BLISTER PACKHistorical
12634-188-541263401885414 in 1 BLISTER PACKHistorical
12634-188-551263401885515 in 1 BLISTER PACKHistorical
12634-188-571263401885720 in 1 BLISTER PACKHistorical
12634-188-711263401887130 in 1 BOTTLEHistorical
12634-188-791263401887925 in 1 BOTTLEHistorical
12634-188-801263401888020 in 1 BOTTLEHistorical
12634-188-811263401888121 in 1 BOTTLEHistorical
12634-188-821263401888212 in 1 BOTTLEHistorical
12634-188-841263401888414 in 1 BOTTLEHistorical
12634-188-851263401888515 in 1 BOTTLEHistorical
12634-188-91126340188911 in 1 BLISTER PACKHistorical