FDA.reportPublic FDA data

Prednisone

Product NDC
59746-175
11-digit product format
597460175
Labeler code
59746
Product ID
59746-175_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
20 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
59746-175-06EA - Each59746-175be403b3c-57b9-4a47-8da4-d6cabb3f4fc612012-07-24
59746-175-09EA - Each59746-175bc0e729c-216f-4cb6-a783-ca2189f3102b12012-07-24
59746-175-10EA - Each59746-1757fc26b50-3348-40ca-9ae5-c5dac08d6e4212012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-175PREDNISONE 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
198145predniSONE 10 MG Oral TabletPSNdc94273f-af06-4bd5-9ce3-ce0a0f36587b22
312615predniSONE 20 MG Oral TabletPSNdc94273f-af06-4bd5-9ce3-ce0a0f36587b22
198145prednisone 10 MG Oral TabletSCDdc94273f-af06-4bd5-9ce3-ce0a0f36587b22
312615prednisone 20 MG Oral TabletSCDdc94273f-af06-4bd5-9ce3-ce0a0f36587b22
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
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
198145predniSONE 10 MG Oral TabletPSNbcc8c648-fc70-44e8-9acc-cdf893097a388
312615predniSONE 20 MG Oral TabletPSNbcc8c648-fc70-44e8-9acc-cdf893097a388
312615predniSONE 20 MG Oral TabletPSN62fdf3c2-cfa9-d573-e053-2a91aa0a833b8
198145prednisone 10 MG Oral TabletSCDbcc8c648-fc70-44e8-9acc-cdf893097a388
312615prednisone 20 MG Oral TabletSCD62fdf3c2-cfa9-d573-e053-2a91aa0a833b8
312615prednisone 20 MG Oral TabletSCDbcc8c648-fc70-44e8-9acc-cdf893097a388
312615predniSONE 20 MG Oral TabletPSNb3dbff9f-610f-7782-e053-2a95a90a71c17
312615prednisone 20 MG Oral TabletSCDb3dbff9f-610f-7782-e053-2a95a90a71c17
312615predniSONE 20 MG Oral TabletPSN62ff1da3-79aa-676a-e053-2991aa0a4a9f6
312615predniSONE 20 MG Oral TabletPSN4e7a8c58-2da2-2f87-e054-00144ff88e886
312615predniSONE 20 MG Oral TabletPSNe4555299-af68-416f-8999-9bb703a45e776
312615prednisone 20 MG Oral TabletSCD62ff1da3-79aa-676a-e053-2991aa0a4a9f6
312615prednisone 20 MG Oral TabletSCD4e7a8c58-2da2-2f87-e054-00144ff88e886
312615prednisone 20 MG Oral TabletSCDe4555299-af68-416f-8999-9bb703a45e776
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
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
198145predniSONE 10 MG Oral TabletPSNdd933616-6988-4535-96b1-3c26d44325364
312615predniSONE 20 MG Oral TabletPSNdd933616-6988-4535-96b1-3c26d44325364
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 TabletSCDdd933616-6988-4535-96b1-3c26d44325364
198145predniSONE 10 MG Oral TabletPSNdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312615predniSONE 20 MG Oral TabletPSNf617ee81-20ff-4c3e-b3af-40a3842bddbf1
312615predniSONE 20 MG Oral TabletPSN83e76d04-cba2-5aee-e053-2a91aa0add6a1
312615predniSONE 20 MG Oral TabletPSN3f4f6272-e051-41f0-a1a1-7abfcc3aa8841
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 TabletSCD3f4f6272-e051-41f0-a1a1-7abfcc3aa8841
312615prednisone 20 MG Oral TabletSCDdc663fd3-b149-48ae-a3f3-6abaa4808cc61
312615prednisone 20 MG Oral TabletSCDf617ee81-20ff-4c3e-b3af-40a3842bddbf1
312615prednisone 20 MG Oral TabletSCD83e76d04-cba2-5aee-e053-2a91aa0add6a1
312617prednisone 5 MG Oral TabletSCDdc663fd3-b149-48ae-a3f3-6abaa4808cc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-175-0659746017506100 TABLET in 1 BOTTLE (59746-175-06) 100 tablet2001-08-290000-00-00NoNoCurrent
59746-175-0959746017509500 TABLET in 1 BOTTLE (59746-175-09) 500 tablet2001-08-290000-00-00NoNoCurrent
59746-175-10597460175101000 TABLET in 1 BOTTLE (59746-175-10) 1000 tablet2001-08-290000-00-00NoNoCurrent