FDA.reportPublic FDA data

Prednisone

Product NDC
21695-765
11-digit product format
216950765
Labeler code
21695
Product ID
21695-765_e99ddb19-8169-4ff4-9e23-16f763e8d7e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-765-212019-09-24C16284748780-1934fe258-47dc-48b1-e053-8cdaa90a720aPredniSONE TABLETS, USP 5 mg and 10 mg
21695-765-482019-09-24C16284748780-1934fe258-47dc-48b1-e053-8cdaa90a720aPredniSONE TABLETS, USP 5 mg and 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-765-21Prednisone21 in 1 BOX, UNIT-DOSETABLET212
21695-765-48Prednisone48 in 1 BOX, UNIT-DOSETABLET482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-765PREDNISONE TABLET [REBEL DISTRIBUTORS CORP]2Legacy NDC, 2 package rows20111220_d3abe47f-8ad5-4752-b772-97b56cca19f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCKd3abe47f-8ad5-4752-b772-97b56cca19f22
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCKd3abe47f-8ad5-4752-b772-97b56cca19f22
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCKd3abe47f-8ad5-4752-b772-97b56cca19f22
198145predniSONE 10 MG Oral TabletPSNd3abe47f-8ad5-4752-b772-97b56cca19f22
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSNd3abe47f-8ad5-4752-b772-97b56cca19f22
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSNd3abe47f-8ad5-4752-b772-97b56cca19f22
312617predniSONE 5 MG Oral TabletPSNd3abe47f-8ad5-4752-b772-97b56cca19f22
763181predniSONE 5 MG Tablet 21 Count PackPSNd3abe47f-8ad5-4752-b772-97b56cca19f22
198145prednisone 10 MG Oral TabletSCDd3abe47f-8ad5-4752-b772-97b56cca19f22
312617prednisone 5 MG Oral TabletSCDd3abe47f-8ad5-4752-b772-97b56cca19f22
763185Prednisone 10 MG Oral Tablet 21 Count PackSYd3abe47f-8ad5-4752-b772-97b56cca19f22
763183Prednisone 10 MG Oral Tablet 48 Count PackSYd3abe47f-8ad5-4752-b772-97b56cca19f22
763181Prednisone 5 MG Oral Tablet 21 Count PackSYd3abe47f-8ad5-4752-b772-97b56cca19f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-765-212169507652121 in 1 BOX, UNIT-DOSEHistorical
21695-765-482169507654848 in 1 BOX, UNIT-DOSEHistorical