FDA.reportPublic FDA data

Prednisone

Product NDC
0591-5052
11-digit product format
005915052
Labeler code
0591
Product ID
0591-5052_6e6cf2e7-c839-4c9f-a58a-fea5023fb432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA080356
Marketing category
ANDA
Marketing start
1990-01-01
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 312615, 312617, 763179, 763181, 763183, 763185

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5052-01Prednisone100 in 1 BOTTLETABLET10017
0591-5052-10Prednisone1000 in 1 BOTTLETABLET100017
0591-5052-21Prednisone1 in 1 CARTONTABLET117
0591-5052-21Prednisone21 in 1 BLISTER PACKTABLET2117
0591-5052-43Prednisone1 in 1 CARTONTABLET117
0591-5052-43Prednisone48 in 1 BLISTER PACKTABLET4817

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5052-01EA - Each0591-5052bc127a8e-4425-427d-bc64-a8994af2648112012-07-24
0591-5052-10EA - Each0591-50522f72ac0f-1d93-46b2-9923-d3feb82c74dc12012-07-24
0591-5052-21EA - Each0591-5052461b9179-6dee-46da-857d-799c7dc2ea8b12016-05-16
0591-5052-43EA - Each0591-505246277346-ed95-47fd-80f8-ceb36817f86a12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [WATSON LABORATORIES, INC.]4
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [WATSON LABORATORIES, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [WATSON LABORATORIES, INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [WATSON LABORATORIES, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [WATSON LABORATORIES, INC.]4
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [WATSON LABORATORIES, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [WATSON LABORATORIES, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [WATSON LABORATORIES, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [WATSON LABORATORIES, INC.]4
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5052PREDNISONE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 6 package rows20250302_aa0b1582-6ef3-4697-9ea6-5391e6e57853.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
312615predniSONE 20 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
312617predniSONE 5 MG Oral TabletPSNde498de3-6ee6-4594-895e-cc69f050e34e36
198145prednisone 10 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36
312615prednisone 20 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36
312617prednisone 5 MG Oral TabletSCDde498de3-6ee6-4594-895e-cc69f050e34e36
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCKaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCKaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCKaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763179{48 (prednisone 5 MG Oral Tablet) } PackGPCKaa0b1582-6ef3-4697-9ea6-5391e6e5785317
198145predniSONE 10 MG Oral TabletPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
312615predniSONE 20 MG Oral TabletPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
312617predniSONE 5 MG Oral TabletPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763179predniSONE 5 MG Tablet 12 Day 48 Count PackPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763181predniSONE 5 MG Tablet 21 Count PackPSNaa0b1582-6ef3-4697-9ea6-5391e6e5785317
198145prednisone 10 MG Oral TabletSCDaa0b1582-6ef3-4697-9ea6-5391e6e5785317
312615prednisone 20 MG Oral TabletSCDaa0b1582-6ef3-4697-9ea6-5391e6e5785317
312617prednisone 5 MG Oral TabletSCDaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763185Prednisone 10 MG Oral Tablet 21 Count PackSYaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763183Prednisone 10 MG Oral Tablet 48 Count PackSYaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763181Prednisone 5 MG Oral Tablet 21 Count PackSYaa0b1582-6ef3-4697-9ea6-5391e6e5785317
763179Prednisone 5 MG Oral Tablet 48 Count PackSYaa0b1582-6ef3-4697-9ea6-5391e6e5785317
312617predniSONE 5 MG Oral TabletPSNf4d5974a-444f-4ef0-84a9-803150ccdeac9
312617prednisone 5 MG Oral TabletSCDf4d5974a-444f-4ef0-84a9-803150ccdeac9
312617predniSONE 5 MG Oral TabletPSN4bd86b2f-75cb-4711-85e2-b81ed947cb137
312617prednisone 5 MG Oral TabletSCD4bd86b2f-75cb-4711-85e2-b81ed947cb137
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCKa1bff575-cd79-4596-99f1-30a5fe8a8b4c6
312617predniSONE 5 MG Oral TabletPSNa1bff575-cd79-4596-99f1-30a5fe8a8b4c6
763181predniSONE 5 MG Tablet 21 Count PackPSNa1bff575-cd79-4596-99f1-30a5fe8a8b4c6
312617prednisone 5 MG Oral TabletSCDa1bff575-cd79-4596-99f1-30a5fe8a8b4c6
763181Prednisone 5 MG Oral Tablet 21 Count PackSYa1bff575-cd79-4596-99f1-30a5fe8a8b4c6
312617predniSONE 5 MG Oral TabletPSN08e33e49-aa46-45bf-99dc-41a8de7e16af5
312617prednisone 5 MG Oral TabletSCD08e33e49-aa46-45bf-99dc-41a8de7e16af5
312617predniSONE 5 MG Oral TabletPSN5205a8a3-e080-65d9-e054-00144ff88e884
312617prednisone 5 MG Oral TabletSCD5205a8a3-e080-65d9-e054-00144ff88e884
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCK373fbdec-9795-4435-9ef8-3151c110f2fa2
312617predniSONE 5 MG Oral TabletPSN373fbdec-9795-4435-9ef8-3151c110f2fa2
763181predniSONE 5 MG Tablet 21 Count PackPSN373fbdec-9795-4435-9ef8-3151c110f2fa2
312617prednisone 5 MG Oral TabletSCD373fbdec-9795-4435-9ef8-3151c110f2fa2
763181Prednisone 5 MG Oral Tablet 21 Count PackSY373fbdec-9795-4435-9ef8-3151c110f2fa2
312617predniSONE 5 MG Oral TabletPSNc72692dd-8f94-434b-b089-c798b90e42131
312617predniSONE 5 MG Oral TabletPSNd2bda01e-c8af-6e75-e053-2a95a90ab5a71
312617predniSONE 5 MG Oral TabletPSN0f82545c-2f3c-474d-93be-f4e89fa04b691
312617prednisone 5 MG Oral TabletSCDc72692dd-8f94-434b-b089-c798b90e42131
312617prednisone 5 MG Oral TabletSCDd2bda01e-c8af-6e75-e053-2a95a90ab5a71
312617prednisone 5 MG Oral TabletSCD0f82545c-2f3c-474d-93be-f4e89fa04b691

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5052-0100591505201100 TABLET in 1 BOTTLE (0591-5052-01) 100 tablet1990-01-010000-00-00NoNoCurrent
0591-5052-10005915052101000 TABLET in 1 BOTTLE (0591-5052-10) 1000 tablet1990-01-010000-00-00NoNoCurrent
0591-5052-21005915052211 BLISTER PACK in 1 CARTON (0591-5052-21) / 21 TABLET in 1 BLISTER PACK1 blister pack2016-05-250000-00-00NoNoCurrent
0591-5052-43005915052431 BLISTER PACK in 1 CARTON (0591-5052-43) / 48 TABLET in 1 BLISTER PACK1 blister pack2016-05-250000-00-00NoNoCurrent