Methylprednisolone Acetate

Product NDC
0781-3132
11-digit product format
007813132
Labeler code
0781
Product ID
0781-3132_7b4e3280-2181-4cde-a5fa-e0caf53417a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE
Labeler
Sandoz Inc
Application
ANDA040794
Marketing category
ANDA
Marketing start
2009-03-05
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE ACETATE
Active strength
80 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-3132DDiscontinued by firm2026-08-17
excluded packagepackage0781-31320781-3132-71DDiscontinued by firm2026-08-17
excluded packagepackage0781-31320781-3132-95DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage0781-3132-71d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-3132-95d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-3132-71f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-3132-95f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-3132-712ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-3132-952ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-3132-71a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-3132-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-3132-71cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-3132-95cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-3132-71cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-3132-95cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-3132-71302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-3132-95302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-3132-71ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-3132-95ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-3132-710efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-3132-950efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-3132-71ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-3132-95ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-3132-71367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-3132-95367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-3132-71557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-3132-95557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040794-001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05
A040794-002METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040794-001AB
A040794-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05caaa826d4ba7…
2026-08-18 06:07:402026-07A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040794-001METHYLPREDNISOLONE ACETATE40MG/MLINJECTABLE / INJECTIONAB2009-03-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040794-002METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2009-03-05bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040794-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040794-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040794-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040794-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040794-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040794-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040794-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040794-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040794-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040794-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040794-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040794-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040794-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040794-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040794-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040794-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040794-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040794-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040794-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040794-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040794-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040794-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040794-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040794-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040794-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040794-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040794-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040794-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040794-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040794-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040794-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040794-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040794-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040794-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040794-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040794-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040794-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040794-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040794-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040794-002AB1bb7c543d1eb4…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3132-71ML - Milliliter0781-313281b04b55-0a87-43d1-a646-efbef92ea81712012-07-24
0781-3132-95ML - Milliliter0781-313258660f81-65a6-40f5-86a5-0c59cba9cc2712012-07-24

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNfaf608f3-a13d-4969-b1a6-bb0bc1de2a8e1
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNfaf608f3-a13d-4969-b1a6-bb0bc1de2a8e1
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDfaf608f3-a13d-4969-b1a6-bb0bc1de2a8e1
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDfaf608f3-a13d-4969-b1a6-bb0bc1de2a8e1