FDA.reportPublic FDA data

Medrol

Product NDC
50090-0092
11-digit product format
500900092
Labeler code
50090
Product ID
50090-0092_c746aa22-6797-4fb2-82fe-d65041dfcbc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA011153
Marketing category
NDA
Marketing start
1957-10-24
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
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 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
50090-0092-02023-01-30C16284748780-1f386c64a-451d-0266-e053-dadaa90a7c1aMedrol ® methylprednisolone tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0092-0Medrol1 in 1 CARTONTABLET115
50090-0092-0Medrol21 in 1 DOSE PACKTABLET2115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0092-0EA - Each50090-0092c0d89b64-6c8a-4e65-8326-8aef4d158cc312019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0092MEDROL (METHYLPREDNISOLONE) TABLET [A-S MEDICATION SOLUTIONS]15Legacy NDC, 2 package rows20200625_080a1789-f2d0-4d31-aa63-08cd703c7779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834023{21 (methylprednisolone 4 MG Oral Tablet [Medrol]) } Pack [Medrol Dosepak]BPCK080a1789-f2d0-4d31-aa63-08cd703c777915
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK080a1789-f2d0-4d31-aa63-08cd703c777915
260330Medrol 4 MG Oral TabletPSN080a1789-f2d0-4d31-aa63-08cd703c777915
834023Medrol Dosepak 4 MG Tablet 6 Day 21 Count PackPSN080a1789-f2d0-4d31-aa63-08cd703c777915
259966methylPREDNISolone 4 MG Oral TabletPSN080a1789-f2d0-4d31-aa63-08cd703c777915
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN080a1789-f2d0-4d31-aa63-08cd703c777915
260330methylprednisolone 4 MG Oral Tablet [Medrol]SBD080a1789-f2d0-4d31-aa63-08cd703c777915
259966methylprednisolone 4 MG Oral TabletSCD080a1789-f2d0-4d31-aa63-08cd703c777915
260330Medrol 4 MG Oral TabletSY080a1789-f2d0-4d31-aa63-08cd703c777915
834023Medrol DosepakSY080a1789-f2d0-4d31-aa63-08cd703c777915
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY080a1789-f2d0-4d31-aa63-08cd703c777915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0092-0500900092001 DOSE PACK in 1 CARTON (50090-0092-0) > 21 TABLET in 1 DOSE PACK1 dose pack2014-11-280000-00-00NoNoCurrent