FDA.reportPublic FDA data

Medrol

Product NDC
0009-0022
11-digit product format
000090022
Labeler code
0009
Product ID
0009-0022_e4a8e5b4-af77-4eca-92de-cd0982969b82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA011153
Marketing category
NDA
Marketing start
1957-10-24
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
Medrol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, 762675, 834023

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
0009-0022-01Medrol25 in 1 BOTTLETABLET2525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0022-01EA - Each0009-002299be8920-2b32-4f66-8213-0311b85b528112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7
SUCROSEINACTIVE INGREDIENTC151H8M554MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA AND UPJOHN COMPANY]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0022MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]24Current NDC, Legacy NDC, 1 package rows20250424_39d5270b-d957-4821-93d6-501b7b9f02d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834023{21 (methylprednisolone 4 MG Oral Tablet [Medrol]) } Pack [Medrol Dosepak]BPCK39d5270b-d957-4821-93d6-501b7b9f02d425
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK39d5270b-d957-4821-93d6-501b7b9f02d425
207138Medrol 16 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
207136Medrol 2 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
207141Medrol 32 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
260330Medrol 4 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
207137Medrol 8 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
834023Medrol Dosepak 4 MG Tablet 6 Day 21 Count PackPSN39d5270b-d957-4821-93d6-501b7b9f02d425
328161methylPREDNISolone 16 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
197969methylPREDNISolone 2 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
197971methylPREDNISolone 32 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
259966methylPREDNISolone 4 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN39d5270b-d957-4821-93d6-501b7b9f02d425
197973methylPREDNISolone 8 MG Oral TabletPSN39d5270b-d957-4821-93d6-501b7b9f02d425
207138methylprednisolone 16 MG Oral Tablet [Medrol]SBD39d5270b-d957-4821-93d6-501b7b9f02d425
207136methylprednisolone 2 MG Oral Tablet [Medrol]SBD39d5270b-d957-4821-93d6-501b7b9f02d425
207141methylprednisolone 32 MG Oral Tablet [Medrol]SBD39d5270b-d957-4821-93d6-501b7b9f02d425
260330methylprednisolone 4 MG Oral Tablet [Medrol]SBD39d5270b-d957-4821-93d6-501b7b9f02d425
207137methylprednisolone 8 MG Oral Tablet [Medrol]SBD39d5270b-d957-4821-93d6-501b7b9f02d425
328161methylprednisolone 16 MG Oral TabletSCD39d5270b-d957-4821-93d6-501b7b9f02d425
197969methylprednisolone 2 MG Oral TabletSCD39d5270b-d957-4821-93d6-501b7b9f02d425
197971methylprednisolone 32 MG Oral TabletSCD39d5270b-d957-4821-93d6-501b7b9f02d425
259966methylprednisolone 4 MG Oral TabletSCD39d5270b-d957-4821-93d6-501b7b9f02d425
197973methylprednisolone 8 MG Oral TabletSCD39d5270b-d957-4821-93d6-501b7b9f02d425
207138Medrol 16 MG Oral TabletSY39d5270b-d957-4821-93d6-501b7b9f02d425
207136Medrol 2 MG Oral TabletSY39d5270b-d957-4821-93d6-501b7b9f02d425
207141Medrol 32 MG Oral TabletSY39d5270b-d957-4821-93d6-501b7b9f02d425
260330Medrol 4 MG Oral TabletSY39d5270b-d957-4821-93d6-501b7b9f02d425
207137Medrol 8 MG Oral TabletSY39d5270b-d957-4821-93d6-501b7b9f02d425
834023Medrol DosepakSY39d5270b-d957-4821-93d6-501b7b9f02d425
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY39d5270b-d957-4821-93d6-501b7b9f02d425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0022-010000900220125 TABLET in 1 BOTTLE (0009-0022-01) 25 tablet1957-10-240000-00-00NoNoCurrent