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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0092IInactivated by FDA2026-08-03
excluded packagepackage50090-009250090-0092-0IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0092-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0092-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0092-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0092-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0092-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0092-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0092-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0092-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0092-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0092-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0092-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0092-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-0092-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-0092-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-0092-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011153-001MEDROLMETHYLPREDNISOLONE4MGTABLET / ORALABRLD, Approved before 1982
N011153-002MEDROLMETHYLPREDNISOLONE2MGTABLET / ORALRLD, Approved before 1982
N011153-003MEDROLMETHYLPREDNISOLONE16MGTABLET / ORALABRLD, Approved before 1982
N011153-004MEDROLMETHYLPREDNISOLONE8MGTABLET / ORALABRLD, Approved before 1982
N011153-005MEDROLMETHYLPREDNISOLONE24MGTABLET / ORALApproved before 1982
N011153-006MEDROLMETHYLPREDNISOLONE32MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N011153-001AB
N011153-003AB
N011153-004AB
N011153-006AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-005MEDROL24MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-005MEDROL24MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-005MEDROL24MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-005MEDROL24MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-005MEDROL24MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-005MEDROL24MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-006MEDROL32MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-001MEDROL4MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-002MEDROL2MGTABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-003MEDROL16MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-004MEDROL8MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 183 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N011153-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011153-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011153-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011153-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011153-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011153-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011153-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011153-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011153-006AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011153-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011153-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011153-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011153-006AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011153-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011153-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011153-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011153-006AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011153-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011153-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011153-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011153-006AB1d06236e962d9…

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethylprednisoloneMETHYLPREDNISOLONEMylan Pharmaceuticals Inc.22dd75d6-f89a-44f7-8ca6-b64c4e9806dd2026-06-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 011153
application number: NDA011153
MethylprednisoloneMETHYLPREDNISOLONENuCare Pharmaceuticals,Inc.bdd233d9-333d-7389-e053-2a95a90a4b422026-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 011153
application number: NDA011153
MedrolMETHYLPREDNISOLONEPharmacia & Upjohn Company LLC39d5270b-d957-4821-93d6-501b7b9f02d42025-11-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 011153
application number: NDA011153
MethylprednisoloneMETHYLPREDNISOLONEREMEDYREPACK INC.d2a0e52c-f724-40e6-9d2a-5f1487c104b62025-09-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 011153
application number: NDA011153

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