Depo-Medrol

Product NDC
70518-1088
11-digit product format
705181088
Labeler code
70518
Product ID
70518-1088_69858dfd-3f2b-37de-e053-2a91aa0afc4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
REMEDYREPACK INC.
Application
NDA011757
Marketing category
NDA
Marketing start
2018-03-29
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct70518-1088DDiscontinued by firm2026-08-07
excluded packagepackage70518-108870518-1088-0DDiscontinued by firm2026-08-07

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 · 24 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 packagepackage70518-1088-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-1088-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-1088-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-1088-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-1088-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-1088-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-1088-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-1088-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-1088-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-1088-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-1088-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-1088-0557ba5c1ecfa…9c80585c8c6e…

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

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N011757-001DEPO-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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011757-002DEPO-MEDROL20MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N011757-004DEPO-MEDROL80MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N011757-001DEPO-MEDROL40MG/MLINJECTABLE / INJECTIONABRLD, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2019-12-13 00:20 UTC2019-12N011757-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N011757-004AB174a2ff9319b5…

FDA-Initiated Inactive NDC Indexing#

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
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