DEPO-MEDROL

Product NDC
50090-1823
11-digit product format
500901823
Labeler code
50090
Product ID
50090-1823_09faf8e7-1a0f-4db3-94b0-090d7a6791e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
A-S Medication Solutions
Application
NDA011757
Marketing category
NDA
Marketing start
1959-05-28
Substance
METHYLPREDNISOLONE ACETATE
Active strength
80 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1823-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1823-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1823-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011757-001DEPO-MEDROLMETHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982
N011757-002DEPO-MEDROLMETHYLPREDNISOLONE ACETATE20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982
N011757-004DEPO-MEDROLMETHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N011757-001AB
N011757-004AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19821e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 101 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N011757-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N011757-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N011757-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N011757-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011757-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N011757-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N011757-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N011757-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011757-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N011757-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011757-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N011757-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011757-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N011757-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011757-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N011757-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011757-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N011757-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011757-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N011757-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N011757-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N011757-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011757-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N011757-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011757-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N011757-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011757-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011757-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N011757-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N011757-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011757-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011757-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N011757-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N011757-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N011757-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N011757-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N011757-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N011757-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N011757-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N011757-001AB174a2ff9319b5…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43502P7F0PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1358617Internal RxNorm lookup
1358619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e8209047-c1e6-4081-a6d3-c603d9ee4f14Available on FDA.report

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
50090-1823-02024-06-22C16284748780-1f386c64a-15e0-0266-e053-dadaa90a7c1aDEPO-MEDROL
50090-1823-02023-01-30C16284748780-1f386c64a-15e0-0266-e053-dadaa90a7c1aDEPO-MEDROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1823-0DEPO-MEDROL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1823-0ML - Milliliter50090-1823e128a29a-0d12-4c0e-9b88-767a4a60a47c12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1823DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 1 package rows20240622_e8209047-c1e6-4081-a6d3-c603d9ee4f14.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLC823b0010-2b57-4e76-b5ac-4a8c2963438f2026-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLC9a7b3837-e038-48bf-97e9-78ad463760dc2026-01-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLCbf1b104d-85cb-414d-a366-78068c82c8832025-12-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionscb457bef-8823-4f3c-987b-eb0922494c462025-11-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionsd75f6751-9ac3-416f-8470-6c011aacf7552025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionse8209047-c1e6-4081-a6d3-c603d9ee4f142025-10-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
ndc (product): 50090-1823
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionsaa151d12-bd33-4d26-848f-2195172c97002024-06-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757
Depo-MedrolMETHYLPREDNISOLONE ACETATEAsclemed USA, Inc.cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b62022-10-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 011757
application number: NDA011757

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358619DEPO-Medrol 80 MG/ML Injectable SuspensionPSNe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358619methylprednisolone acetate 80 MG/ML Injectable Suspension [Depo-Medrol]SBDe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDe8209047-c1e6-4081-a6d3-c603d9ee4f1414
1358619Depo-Medrol 80 MG/ML Injectable SuspensionSYe8209047-c1e6-4081-a6d3-c603d9ee4f1414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1823-0500901823005 mL in 1 VIAL, MULTI-DOSE (50090-1823-0) 5 ml2015-05-130000-00-00NoNoCurrent