Prednisolone

Product NDC
63187-466
11-digit product format
631870466
Labeler code
63187
Product ID
63187-466_387169e5-fdc7-4bd8-94f5-ce71571dd90e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040401
Marketing category
ANDA
Marketing start
2003-02-27
Marketing end
0000-00-00
Substance
PREDNISOLONE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISOLONEACTIVE INGREDIENT9PHQ9Y1OLMPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
PREDNISOLONEACTIVE MOIETY9PHQ9Y1OLMPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
CHERRYINACTIVE INGREDIENTBUC5I9595WPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREDNISOLONE SOLUTION [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPREDNISOLONE SOLUTION [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PREDNISOLONE SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RPREDNISOLONE SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-466PREDNISOLONE SOLUTION [PROFICIENT RX LP]3Legacy NDC20200219_246703b1-a792-4653-a391-02d3c6212cb7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-466-64631870466641 BOTTLE in 1 CARTON (63187-466-64) > 240 mL in 1 BOTTLE1 bottle2019-01-010000-00-00NoNoCurrent