FDA.reportPublic FDA data

Methylprednisolone

Product NDC
59762-0049
11-digit product format
597620049
Labeler code
59762
Product ID
59762-0049_757e97bc-e224-4e63-819b-2f3213428207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA011153
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-03-25
Substance
METHYLPREDNISOLONE
Active strength
8 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui197971, 197973, 259966, 328161, 762675

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0049-1Methylprednisolone25 in 1 BOTTLETABLET2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0049-1EA - Each59762-00493e5abfc6-5a5e-400d-859c-371a35fc253912013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMETHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMETHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMETHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [GREENSTONE LLC]6
SUCROSEINACTIVE INGREDIENTC151H8M554METHYLPREDNISOLONE TABLET [GREENSTONE LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0049METHYLPREDNISOLONE TABLET [MYLAN PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 1 package rows20250524_22dd75d6-f89a-44f7-8ca6-b64c4e9806dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
328161methylPREDNISolone 16 MG Oral TabletPSN22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
197971methylPREDNISolone 32 MG Oral TabletPSN22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
259966methylPREDNISolone 4 MG Oral TabletPSN22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
197973methylPREDNISolone 8 MG Oral TabletPSN22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
328161methylprednisolone 16 MG Oral TabletSCD22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
197971methylprednisolone 32 MG Oral TabletSCD22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
259966methylprednisolone 4 MG Oral TabletSCD22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
197973methylprednisolone 8 MG Oral TabletSCD22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY22dd75d6-f89a-44f7-8ca6-b64c4e9806dd19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-0049-15976200490125 TABLET in 1 BOTTLE (59762-0049-1) 25 tablet2013-03-250000-00-00NoNoCurrent