FDA.reportPublic FDA data

Prednisone

Product NDC
0591-5442
11-digit product format
005915442
Labeler code
0591
Product ID
0591-5442_6e6cf2e7-c839-4c9f-a58a-fea5023fb432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA085162
Marketing category
ANDA
Marketing start
1990-01-01
Substance
PREDNISONE
Active strength
10 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
PREDNISONE10 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
0591-5442-01Prednisone100 in 1 BOTTLETABLET10017
0591-5442-05Prednisone500 in 1 BOTTLETABLET50017
0591-5442-10Prednisone1000 in 1 BOTTLETABLET100017
0591-5442-21Prednisone21 in 1 BLISTER PACKTABLET2117
0591-5442-21Prednisone1 in 1 CARTONTABLET117
0591-5442-43Prednisone1 in 1 CARTONTABLET117
0591-5442-43Prednisone48 in 1 BLISTER PACKTABLET4817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5442PREDNISONE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 7 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
198145predniSONE 10 MG Oral TabletPSNdba51ab3-03df-4a31-a968-1e9fd445121f12
198145prednisone 10 MG Oral TabletSCDdba51ab3-03df-4a31-a968-1e9fd445121f12
198145predniSONE 10 MG Oral TabletPSN94f8ec56-667e-4eda-832d-f2936f12dc369
198145prednisone 10 MG Oral TabletSCD94f8ec56-667e-4eda-832d-f2936f12dc369
198145predniSONE 10 MG Oral TabletPSN0f377d9f-b2f4-4dae-b503-5f963bea281f6
198145predniSONE 10 MG Oral TabletPSN07fb8daa-2ceb-4564-b0d0-6cdf903da0b56
198145prednisone 10 MG Oral TabletSCD07fb8daa-2ceb-4564-b0d0-6cdf903da0b56
198145prednisone 10 MG Oral TabletSCD0f377d9f-b2f4-4dae-b503-5f963bea281f6
198145predniSONE 10 MG Oral TabletPSNc8bc83d5-b9e2-4d31-a3df-8e899aac1ba55
198145prednisone 10 MG Oral TabletSCDc8bc83d5-b9e2-4d31-a3df-8e899aac1ba55
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCK41ade439-59f2-dfd1-e063-6294a90aca0f2
198145predniSONE 10 MG Oral TabletPSN03aaf69f-d9c7-433c-baea-9c6eca0fe1e52
198145predniSONE 10 MG Oral TabletPSN41ade439-59f2-dfd1-e063-6294a90aca0f2
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSN41ade439-59f2-dfd1-e063-6294a90aca0f2
198145prednisone 10 MG Oral TabletSCD41ade439-59f2-dfd1-e063-6294a90aca0f2
198145prednisone 10 MG Oral TabletSCD03aaf69f-d9c7-433c-baea-9c6eca0fe1e52
763185Prednisone 10 MG Oral Tablet 21 Count PackSY41ade439-59f2-dfd1-e063-6294a90aca0f2
198145predniSONE 10 MG Oral TabletPSN309580a7-c3bb-e53b-e063-6394a90a15631
198145predniSONE 10 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
198145predniSONE 10 MG Oral TabletPSN11bd1f28-074e-3df7-e054-00144ff88e881
312615predniSONE 20 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
198145prednisone 10 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881
198145prednisone 10 MG Oral TabletSCD309580a7-c3bb-e53b-e063-6394a90a15631
198145prednisone 10 MG Oral TabletSCD11bd1f28-074e-3df7-e054-00144ff88e881
312615prednisone 20 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5442-000059154420047000 TABLET in 1 BAG (0591-5442-00)47000 tablet01-NOV-87Current
0591-5442-0100591544201100 TABLET in 1 BOTTLE (0591-5442-01) 100 tablet1990-01-010000-00-00NoNoCurrent
0591-5442-0500591544205500 TABLET in 1 BOTTLE (0591-5442-05) 500 tablet1990-01-010000-00-00NoNoCurrent
0591-5442-10005915442101000 TABLET in 1 BOTTLE (0591-5442-10) 1000 tablet1993-05-180000-00-00NoNoCurrent
0591-5442-21005915442211 BLISTER PACK in 1 CARTON (0591-5442-21) / 21 TABLET in 1 BLISTER PACK1 blister pack2016-05-250000-00-00NoNoCurrent
0591-5442-43005915442431 BLISTER PACK in 1 CARTON (0591-5442-43) / 48 TABLET in 1 BLISTER PACK1 blister pack2016-05-250000-00-00NoNoCurrent
0591-5442-770059154427756604 TABLET in 1 CONTAINER (0591-5442-77)56604 tablet30-JUN-24Current