FDA.reportPublic FDA data

Prednisone

Product NDC
63187-037
11-digit product format
631870037
Labeler code
63187
Product ID
63187-037_c1b5fac9-ec3d-491f-8e58-bba1d0f9d861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
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, 312617

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-037-05Prednisone5 in 1 BOTTLE, PLASTICTABLET59
63187-037-08Prednisone8 in 1 BOTTLE, PLASTICTABLET89
63187-037-09Prednisone9 in 1 BOTTLE, PLASTICTABLET99
63187-037-10Prednisone10 in 1 BOTTLE, PLASTICTABLET109
63187-037-20Prednisone20 in 1 BOTTLE, PLASTICTABLET209
63187-037-21Prednisone21 in 1 BOTTLE, PLASTICTABLET219
63187-037-30Prednisone30 in 1 BOTTLE, PLASTICTABLET309
63187-037-40Prednisone40 in 1 BOTTLE, PLASTICTABLET409
63187-037-42Prednisone42 in 1 BOTTLE, PLASTICTABLET429

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-037PREDNISONE TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 9 package rows20210508_7d52bf53-76e3-4826-a12b-b16a8560bafc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN7d52bf53-76e3-4826-a12b-b16a8560bafc9
312617predniSONE 5 MG Oral TabletPSN7d52bf53-76e3-4826-a12b-b16a8560bafc9
198145prednisone 10 MG Oral TabletSCD7d52bf53-76e3-4826-a12b-b16a8560bafc9
312617prednisone 5 MG Oral TabletSCD7d52bf53-76e3-4826-a12b-b16a8560bafc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-037-05631870037055 TABLET in 1 BOTTLE, PLASTIC (63187-037-05) 5 tablet2014-08-010000-00-00NoNoCurrent
63187-037-08631870037088 TABLET in 1 BOTTLE, PLASTIC (63187-037-08) 8 tablet2014-08-010000-00-00NoNoCurrent
63187-037-09631870037099 TABLET in 1 BOTTLE, PLASTIC (63187-037-09) 9 tablet2014-08-010000-00-00NoNoCurrent
63187-037-106318700371010 TABLET in 1 BOTTLE, PLASTIC (63187-037-10) 10 tablet2014-08-010000-00-00NoNoCurrent
63187-037-206318700372020 TABLET in 1 BOTTLE, PLASTIC (63187-037-20) 20 tablet2014-08-010000-00-00NoNoCurrent
63187-037-216318700372121 TABLET in 1 BOTTLE, PLASTIC (63187-037-21) 21 tablet2014-08-010000-00-00NoNoCurrent
63187-037-306318700373030 TABLET in 1 BOTTLE, PLASTIC (63187-037-30) 30 tablet2014-08-010000-00-00NoNoCurrent
63187-037-406318700374040 TABLET in 1 BOTTLE, PLASTIC (63187-037-40) 40 tablet2014-08-010000-00-00NoNoCurrent
63187-037-426318700374242 TABLET in 1 BOTTLE, PLASTIC (63187-037-42) 42 tablet2014-08-010000-00-00NoNoCurrent