PredniSONE

Product NDC
63187-243
11-digit product format
631870243
Labeler code
63187
Product ID
63187-243_1763b844-f261-4cdc-9a93-43d13a64da0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA084283
Marketing category
ANDA
Marketing start
2003-03-14
Substance
PREDNISONE
Active strength
50 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
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198148

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
63187-243-05PredniSONE5 in 1 BOTTLE, PLASTICTABLET56
63187-243-07PredniSONE7 in 1 BOTTLE, PLASTICTABLET76
63187-243-08PredniSONE8 in 1 BOTTLE, PLASTICTABLET86
63187-243-10PredniSONE10 in 1 BOTTLE, PLASTICTABLET106
63187-243-15PredniSONE15 in 1 BOTTLE, PLASTICTABLET156
63187-243-20PredniSONE20 in 1 BOTTLE, PLASTICTABLET206
63187-243-21PredniSONE21 in 1 BOTTLE, PLASTICTABLET216
63187-243-30PredniSONE30 in 1 BOTTLE, PLASTICTABLET306
63187-243-40PredniSONE40 in 1 BOTTLE, PLASTICTABLET406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-243-05EA - Each63187-24342303d23-584e-4841-9589-e97293a108c612016-10-06
63187-243-07EA - Each63187-2433e709030-1c46-4143-91bc-1a6a935ff81612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [PROFICIENT RX LP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-243PREDNISONE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 9 package rows20220604_e109f428-ca85-4a2c-acd0-ca8d498e7723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSNe109f428-ca85-4a2c-acd0-ca8d498e77236
198148prednisone 50 MG Oral TabletSCDe109f428-ca85-4a2c-acd0-ca8d498e77236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-243-05631870243055 TABLET in 1 BOTTLE, PLASTIC (63187-243-05) 5 tablet2014-09-010000-00-00NoNoCurrent
63187-243-07631870243077 TABLET in 1 BOTTLE, PLASTIC (63187-243-07) 7 tablet2022-05-270000-00-00NoNoCurrent
63187-243-08631870243088 TABLET in 1 BOTTLE, PLASTIC (63187-243-08) 8 tablet2014-09-010000-00-00NoNoCurrent
63187-243-106318702431010 TABLET in 1 BOTTLE, PLASTIC (63187-243-10) 10 tablet2014-09-010000-00-00NoNoCurrent
63187-243-156318702431515 TABLET in 1 BOTTLE, PLASTIC (63187-243-15) 15 tablet2014-09-010000-00-00NoNoCurrent
63187-243-206318702432020 TABLET in 1 BOTTLE, PLASTIC (63187-243-20) 20 tablet2014-09-010000-00-00NoNoCurrent
63187-243-216318702432121 TABLET in 1 BOTTLE, PLASTIC (63187-243-21) 21 tablet2014-09-010000-00-00NoNoCurrent
63187-243-306318702433030 TABLET in 1 BOTTLE, PLASTIC (63187-243-30) 30 tablet2014-09-010000-00-00NoNoCurrent
63187-243-406318702434040 TABLET in 1 BOTTLE, PLASTIC (63187-243-40) 40 tablet2014-09-010000-00-00NoNoCurrent