Methylprednisolone

Product NDC
68387-170
11-digit product format
683870170
Labeler code
68387
Product ID
68387-170_3bea99e4-ca58-4fb1-b08d-f482b136a5ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
NDA011153
Marketing category
NDA
Marketing start
2007-09-14
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-170-012019-10-21C16284748780-1956f9ecf-d95f-621f-e053-dbdaa90a74adMethylprednisolone tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-170-01Methylprednisolone1 in 1 BAGTABLET11
68387-170-01Methylprednisolone21 in 1 DOSE PACKTABLET211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-170-01EA - Each68387-17044ec4f34-d19d-45ba-aba1-bd8719fb3fe712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
methylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-170METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20100901_0d807b7a-2942-4b13-b3c5-a585ff56fe32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK0d807b7a-2942-4b13-b3c5-a585ff56fe321
259966methylPREDNISolone 4 MG Oral TabletPSN0d807b7a-2942-4b13-b3c5-a585ff56fe321
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN0d807b7a-2942-4b13-b3c5-a585ff56fe321
259966methylprednisolone 4 MG Oral TabletSCD0d807b7a-2942-4b13-b3c5-a585ff56fe321
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY0d807b7a-2942-4b13-b3c5-a585ff56fe321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-170-01683870170011 in 1 BAGHistorical