Methylprednisolone

Product NDC
68788-4593
11-digit product format
687884593
Labeler code
68788
Product ID
68788-4593_6c96b7a0-9907-438e-a61b-da0966943e2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040189
Marketing category
ANDA
Marketing start
2013-09-03
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4593-2EA - Each68788-45937926cea1-dce8-4d56-b239-d6cb34f679b112024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-4593METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]8Legacy NDC20240716_ebe4f4a5-3fec-4f30-8289-25e594162c49.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-4593-26878845930221 TABLET in 1 BLISTER PACK (68788-4593-2) 21 tablet2013-09-030000-00-00NoNoCurrent