Methylprednisolone

Product NDC
68001-559
11-digit product format
680010559
Labeler code
68001
Product ID
68001-559_ee3732c9-52c6-1424-e053-2995a90a7694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA040189
Marketing category
ANDA
Marketing start
2022-09-29
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
16 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
68001-559-69EA - Each68001-5595980acd4-a32b-44ff-b056-391b37481fb212022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-559METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]11Legacy NDC20240229_a91f119c-9765-4a6f-b636-4470d11dc3d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-559-696800105596950 TABLET in 1 BOTTLE (68001-559-69) 50 tablet2022-09-290000-00-00NoNoCurrent