Methylprednisolone Sodium Succinate

Product NDC
25021-807
11-digit product format
250210807
Labeler code
25021
Product ID
25021-807_0bf9d0ea-b703-4eca-aab3-198f495ce63c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Sodium Succinate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA040888
Marketing category
ANDA
Marketing start
2017-03-15
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct25021-807DDiscontinued by firm2026-10-23
excluded packagepackage25021-80725021-807-05DDiscontinued by firm2026-10-23

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 packagepackage25021-807-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage25021-807-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage25021-807-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage25021-807-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage25021-807-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage25021-807-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage25021-807-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage25021-807-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage25021-807-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage25021-807-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage25021-807-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage25021-807-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18
A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18
A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18
A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18
A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A040888-001AP
A040888-002AP
A040888-003AP
A040888-004AP
A040888-005AP

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 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18c2088c7a36db…
2026-09-14 22:38:342026-08A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-1884e616aacf4f…
2026-08-18 06:07:402026-07A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2011-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2011-07-18b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A040888-001AP1c2088c7a36db…
2026-10-15 13:18:302026-09A040888-002AP1c2088c7a36db…
2026-10-15 13:18:302026-09A040888-003AP1c2088c7a36db…
2026-10-15 13:18:302026-09A040888-004AP1c2088c7a36db…
2026-10-15 13:18:302026-09A040888-005AP1c2088c7a36db…
2026-09-14 22:38:342026-08A040888-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A040888-002AP184e616aacf4f…
2026-09-14 22:38:342026-08A040888-003AP184e616aacf4f…
2026-09-14 22:38:342026-08A040888-004AP184e616aacf4f…
2026-09-14 22:38:342026-08A040888-005AP184e616aacf4f…
2026-08-18 06:07:402026-07A040888-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A040888-005AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040888-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040888-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040888-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040888-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040888-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040888-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040888-005AP1b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-807-05EA - Each25021-8078de34613-21e2-478e-b9fc-9bd2c7c5d4a912017-05-03