FDA.reportPublic FDA data

Prednisone

Product NDC
0591-5443
11-digit product format
005915443
Labeler code
0591
Product ID
0591-5443_6e6cf2e7-c839-4c9f-a58a-fea5023fb432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA085161
Marketing category
ANDA
Marketing start
1990-01-01
Substance
PREDNISONE
Active strength
20 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
PREDNISONE20 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
0591-5443-01Prednisone100 in 1 BOTTLETABLET10017
0591-5443-05Prednisone500 in 1 BOTTLETABLET50017
0591-5443-10Prednisone1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5443-01EA - Each0591-5443510d2d03-dd69-4948-8b8d-5a4621996bac12012-07-24
0591-5443-05EA - Each0591-54431b53e9ce-d00d-44ea-beaf-fc67a9f204d012012-07-24
0591-5443-10EA - Each0591-54439b01763c-5a62-4527-ae64-06c294d8756512012-07-24

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 [BLENHEIM PHARMACAL, INC.]1
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5443PREDNISONE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 3 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
312615predniSONE 20 MG Oral TabletPSNa6811c1f-3dad-46bb-b541-fddd2ff8e56911
312615prednisone 20 MG Oral TabletSCDa6811c1f-3dad-46bb-b541-fddd2ff8e56911
312615predniSONE 20 MG Oral TabletPSNd9b1652b-820a-4971-ab71-58bd55908b4d9
312615prednisone 20 MG Oral TabletSCDd9b1652b-820a-4971-ab71-58bd55908b4d9
312615predniSONE 20 MG Oral TabletPSN81695f4d-b975-691e-e053-2991aa0a5d638
312615prednisone 20 MG Oral TabletSCD81695f4d-b975-691e-e053-2991aa0a5d638
312615predniSONE 20 MG Oral TabletPSNd898d53f-c7d2-4bdb-bd9e-5f200070d1237
312615prednisone 20 MG Oral TabletSCDd898d53f-c7d2-4bdb-bd9e-5f200070d1237
312615predniSONE 20 MG Oral TabletPSN13a6f44a-c0b9-48b0-8577-bc1120381a336
312615prednisone 20 MG Oral TabletSCD13a6f44a-c0b9-48b0-8577-bc1120381a336
312615predniSONE 20 MG Oral TabletPSNf6cb7924-4190-f130-e053-6294a90a21fe4
312615predniSONE 20 MG Oral TabletPSN016d65c3-fff2-4e0c-9025-e2083cfa6a1f4
312615predniSONE 20 MG Oral TabletPSN7e541478-4a33-189f-e053-2a91aa0a69624
312615prednisone 20 MG Oral TabletSCD7e541478-4a33-189f-e053-2a91aa0a69624
312615prednisone 20 MG Oral TabletSCDf6cb7924-4190-f130-e053-6294a90a21fe4
312615prednisone 20 MG Oral TabletSCD016d65c3-fff2-4e0c-9025-e2083cfa6a1f4
198145predniSONE 10 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
312615predniSONE 20 MG Oral TabletPSN92ad0264-035e-b12a-e053-2a95a90a684e1
312615predniSONE 20 MG Oral TabletPSN91ce3df8-9d2b-5479-e053-2a95a90aab841
312615predniSONE 20 MG Oral TabletPSN8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615predniSONE 20 MG Oral TabletPSN8e6dceeb-132f-f12d-e053-2995a90a22411
312615predniSONE 20 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
198145prednisone 10 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881
312615prednisone 20 MG Oral TabletSCD92ad0264-035e-b12a-e053-2a95a90a684e1
312615prednisone 20 MG Oral TabletSCD91ce3df8-9d2b-5479-e053-2a95a90aab841
312615prednisone 20 MG Oral TabletSCD8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615prednisone 20 MG Oral TabletSCD8e6dceeb-132f-f12d-e053-2995a90a22411
312615prednisone 20 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5443-000059154430031000 TABLET in 1 BAG (0591-5443-00)31000 tablet01-NOV-87Current
0591-5443-0100591544301100 TABLET in 1 BOTTLE (0591-5443-01) 100 tablet1990-01-010000-00-00NoNoCurrent
0591-5443-0500591544305500 TABLET in 1 BOTTLE (0591-5443-05) 500 tablet1990-01-010000-00-00NoNoCurrent
0591-5443-10005915443101000 TABLET in 1 BOTTLE (0591-5443-10) 1000 tablet1993-11-110000-00-00NoNoCurrent
0591-5443-770059154437736912 TABLET in 1 CONTAINER (0591-5443-77)36912 tablet30-JUN-24Current