Methylprednisolone

Product NDC
50436-4037
11-digit product format
504364037
Labeler code
50436
Product ID
50436-4037_f95eb5eb-4c6a-440a-9492-b0926e78adb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040189
Marketing category
ANDA
Marketing start
1997-10-31
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
2020-12-31
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
50436-4037-12021-01-29C16284748780-1ba0f9c33-3933-a910-e053-dadaa90a0b85METHYLPREDNISOLONE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4037-1Methylprednisolone21 in 1 BOTTLETABLET214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4037-1EA - Each50436-4037777caa8f-933a-4add-bde7-76de64a4ee6412013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4037METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20190129_694cc762-834a-4dd8-9757-eeead4e2e553.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylPREDNISolone 4 MG Oral TabletPSN694cc762-834a-4dd8-9757-eeead4e2e5534
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylprednisolone 4 MG Oral TabletSCD694cc762-834a-4dd8-9757-eeead4e2e5534
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY694cc762-834a-4dd8-9757-eeead4e2e5534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4037-15043640370121 in 1 BOTTLEHistorical