FDA.reportPublic FDA data

MethylPREDNISolone

Product NDC
55045-1259
11-digit product format
550451259
Labeler code
55045
Product ID
55045-1259_93aefabb-b384-40ef-9d3f-f8dee3b21f1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA040183
Marketing category
ANDA
Marketing start
1998-12-22
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
55045-1259-92019-10-29C16284748780-1960f7f55-d052-8e05-e053-dbdaa90a074aMethylPREDNISolone TABLETS, USP 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-1259-9MethylPREDNISolone21 in 1 BOTTLE, PLASTICTABLET212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55045-1259-9EA - Each55045-12599cfff942-0a10-42ca-8baa-0be20582288612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-1259METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20110923_2eb5d8c3-87dd-47dc-9619-461dfb7ba935.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
259966methylPREDNISolone 4 MG Oral TabletPSN2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
259966methylprednisolone 4 MG Oral TabletSCD2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY2eb5d8c3-87dd-47dc-9619-461dfb7ba9352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55045-1259-95504512590921 in 1 BOTTLE, PLASTICHistorical