FDA.reportPublic FDA data

Prednisone

Product NDC
59746-172
11-digit product format
597460172
Labeler code
59746
Product ID
59746-172_3b1247fb-3a8d-4c94-b26a-a61398316cc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS INC.
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-172-06EA - Each59746-172502aff9a-1dd9-4d5e-9a91-c03d44f783e412012-07-24
59746-172-10EA - Each59746-172b23cd0d0-45f3-4d4c-9290-8ceb09d36f5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoneACTIVE INGREDIENTVB0R961HZTPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
PrednisoneACTIVE MOIETYVB0R961HZTPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TPREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]3
PrednisoneACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
PrednisoneACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [PROFICIENT RX LP]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PROFICIENT RX LP]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPREDNISONE TABLET [PROFICIENT RX LP]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PROFICIENT RX LP]1
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TPREDNISONE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-172PREDNISONE TABLET PREDNISONE (PREDNISONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]9Legacy NDC20240526_931ceb82-23b9-46c6-a00b-4cd66ed6f88f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312617predniSONE 5 MG Oral TabletPSN751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312615prednisone 20 MG Oral TabletSCD751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312617prednisone 5 MG Oral TabletSCD751b7f62-f92b-4b7c-a588-2c882d5d1ce321
312617predniSONE 5 MG Oral TabletPSN5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d219
312617prednisone 5 MG Oral TabletSCD5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d219
312617predniSONE 5 MG Oral TabletPSN74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf16
312617prednisone 5 MG Oral TabletSCD74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf16
198145predniSONE 10 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312615predniSONE 20 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
312617predniSONE 5 MG Oral TabletPSN70003b50-1802-436d-9bee-3e2e4858e46115
198145prednisone 10 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312615prednisone 20 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312617prednisone 5 MG Oral TabletSCD70003b50-1802-436d-9bee-3e2e4858e46115
312617predniSONE 5 MG Oral TabletPSN4eca8a3b-27d4-595a-e054-00144ff88e888
312617prednisone 5 MG Oral TabletSCD4eca8a3b-27d4-595a-e054-00144ff88e888
312617predniSONE 5 MG Oral TabletPSN74715d18-63e6-cbf6-e053-2991aa0a5c387
312617prednisone 5 MG Oral TabletSCD74715d18-63e6-cbf6-e053-2991aa0a5c387
312617predniSONE 5 MG Oral TabletPSNa526d12d-b358-4d83-804e-b34e5f52a7fa6
312617predniSONE 5 MG Oral TabletPSNaf863b9e-964b-3b1e-e053-2995a90ab93a6
312617prednisone 5 MG Oral TabletSCDa526d12d-b358-4d83-804e-b34e5f52a7fa6
312617prednisone 5 MG Oral TabletSCDaf863b9e-964b-3b1e-e053-2995a90ab93a6
198145predniSONE 10 MG Oral TabletPSN1418d2f2-07d5-407a-81ca-380a5615b5b45
312615predniSONE 20 MG Oral TabletPSN1418d2f2-07d5-407a-81ca-380a5615b5b45
312617predniSONE 5 MG Oral TabletPSN1418d2f2-07d5-407a-81ca-380a5615b5b45
312617predniSONE 5 MG Oral TabletPSNb3dbf833-b929-8c85-e053-2995a90a58965
198145prednisone 10 MG Oral TabletSCD1418d2f2-07d5-407a-81ca-380a5615b5b45
312615prednisone 20 MG Oral TabletSCD1418d2f2-07d5-407a-81ca-380a5615b5b45
312617prednisone 5 MG Oral TabletSCD1418d2f2-07d5-407a-81ca-380a5615b5b45
312617prednisone 5 MG Oral TabletSCDb3dbf833-b929-8c85-e053-2995a90a58965
198145predniSONE 10 MG Oral TabletPSNdd933616-6988-4535-96b1-3c26d44325364
312615predniSONE 20 MG Oral TabletPSNdd933616-6988-4535-96b1-3c26d44325364
312617predniSONE 5 MG Oral TabletPSN7c650dc8-43f6-4257-81ed-c93b00202d064
312617predniSONE 5 MG Oral TabletPSNdd933616-6988-4535-96b1-3c26d44325364
198145prednisone 10 MG Oral TabletSCDdd933616-6988-4535-96b1-3c26d44325364
312615prednisone 20 MG Oral TabletSCDdd933616-6988-4535-96b1-3c26d44325364
312617prednisone 5 MG Oral TabletSCD7c650dc8-43f6-4257-81ed-c93b00202d064
312617prednisone 5 MG Oral TabletSCDdd933616-6988-4535-96b1-3c26d44325364
312617predniSONE 5 MG Oral TabletPSN63748917-39d3-7156-e053-2a91aa0a94bc3
312617prednisone 5 MG Oral TabletSCD63748917-39d3-7156-e053-2a91aa0a94bc3
312617predniSONE 5 MG Oral TabletPSNd6246d5f-bf2b-4850-978e-6ea3148de0952
312617predniSONE 5 MG Oral TabletPSN22cc98ea-4cc3-40a3-a18d-673f8f26eb952
312617prednisone 5 MG Oral TabletSCDd6246d5f-bf2b-4850-978e-6ea3148de0952
312617prednisone 5 MG Oral TabletSCD22cc98ea-4cc3-40a3-a18d-673f8f26eb952
198145predniSONE 10 MG Oral TabletPSNdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312615predniSONE 20 MG Oral TabletPSNdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312617predniSONE 5 MG Oral TabletPSNdc663fd3-b149-48ae-a3f3-6abaa4808cc61
198145prednisone 10 MG Oral TabletSCDdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312615prednisone 20 MG Oral TabletSCDdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312617prednisone 5 MG Oral TabletSCDdc663fd3-b149-48ae-a3f3-6abaa4808cc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-172-0659746017206100 TABLET in 1 BOTTLE (59746-172-06) 100 tablet2001-08-290000-00-00NoNoCurrent
59746-172-10597460172101000 TABLET in 1 BOTTLE (59746-172-10) 1000 tablet2001-08-290000-00-00NoNoCurrent