FDA.reportPublic FDA data

Prednisone

Product NDC
0603-5336
11-digit product format
006035336
Labeler code
0603
Product ID
0603-5336_e6628b5c-a3e4-462b-a01a-695ed8d3ab64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040581
Marketing category
ANDA
Marketing start
2004-12-21
Substance
PREDNISONE
Active strength
2.5 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198144, 198145, 198146, 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
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0603-5336-212022-08-19C16284748780-1e4f33bdf-9b63-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5336-212022-08-19C16284748780-1e4f33bdf-9b63-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5336-212022-07-29C16284748780-1e4f33bdf-9b63-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only
0603-5336-212022-07-29C16284748780-1e4f33bdf-9b63-d8a0-e053-dadaa90a6e4ePredniSONE Tablets, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-5336-21Prednisone100 in 1 BOTTLE, PLASTICTABLET10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5336-21EA - Each0603-5336111739cf-bf0b-455c-80e4-fec4bf452bdc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [QUALITEST PHARMACEUTICALS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5336PREDNISONE TABLET [ENDO USA, INC.]32Current NDC, Legacy NDC, 1 package rows20240927_10fe5a3b-84dc-4600-87c2-b80c97ce18cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198146predniSONE 2.5 MG Oral TabletPSN6c0376c4-87cf-40dc-b140-a6aac75b64f7104
198146prednisone 2.5 MG Oral TabletSCD6c0376c4-87cf-40dc-b140-a6aac75b64f7104
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179{48 (prednisone 5 MG Oral Tablet) } PackGPCK10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198144predniSONE 1 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198145predniSONE 10 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198146predniSONE 2.5 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312615predniSONE 20 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312617predniSONE 5 MG Oral TabletPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179predniSONE 5 MG Tablet 12 Day 48 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181predniSONE 5 MG Tablet 21 Count PackPSN10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198144prednisone 1 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198145prednisone 10 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
198146prednisone 2.5 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312615prednisone 20 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
312617prednisone 5 MG Oral TabletSCD10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763185Prednisone 10 MG Oral Tablet 21 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183Prednisone 10 MG Oral Tablet 48 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763181Prednisone 5 MG Oral Tablet 21 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763179Prednisone 5 MG Oral Tablet 48 Count PackSY10fe5a3b-84dc-4600-87c2-b80c97ce18cf32
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCKefe0c82b-9dd9-4729-b06f-06307867aca018
198145predniSONE 10 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSNefe0c82b-9dd9-4729-b06f-06307867aca018
198146predniSONE 2.5 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
312615predniSONE 20 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
312617predniSONE 5 MG Oral TabletPSNefe0c82b-9dd9-4729-b06f-06307867aca018
198145prednisone 10 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
198146prednisone 2.5 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
312615prednisone 20 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
312617prednisone 5 MG Oral TabletSCDefe0c82b-9dd9-4729-b06f-06307867aca018
763183Prednisone 10 MG Oral Tablet 48 Count PackSYefe0c82b-9dd9-4729-b06f-06307867aca018
198146predniSONE 2.5 MG Oral TabletPSNfaf6c0c5-e5f4-4de5-e053-6294a90abd1a4
198146prednisone 2.5 MG Oral TabletSCDfaf6c0c5-e5f4-4de5-e053-6294a90abd1a4
198145predniSONE 10 MG Oral TabletPSN2bd7831d-466e-1818-e054-00144ff8d46c1
198146predniSONE 2.5 MG Oral TabletPSN2d99223a-853a-7640-e063-6394a90a260a1
198146predniSONE 2.5 MG Oral TabletPSN2bd7831d-466e-1818-e054-00144ff8d46c1
312617predniSONE 5 MG Oral TabletPSN2bd7831d-466e-1818-e054-00144ff8d46c1
198145prednisone 10 MG Oral TabletSCD2bd7831d-466e-1818-e054-00144ff8d46c1
198146prednisone 2.5 MG Oral TabletSCD2d99223a-853a-7640-e063-6394a90a260a1
198146prednisone 2.5 MG Oral TabletSCD2bd7831d-466e-1818-e054-00144ff8d46c1
312617prednisone 5 MG Oral TabletSCD2bd7831d-466e-1818-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5336-2100603533621100 TABLET in 1 BOTTLE, PLASTIC (0603-5336-21) 100 tablet2004-12-210000-00-00NoNoCurrent