Methylprednisolone Sodium Succinate

Product NDC
82094-405
11-digit product format
820940405
Labeler code
82094
Product ID
82094-405_94c8ce6b-7622-4d1f-8b54-0ce959752ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Tianjin Kingyork Pharmaceuticals Co., Ltd
Application
ANDA212396
Marketing category
ANDA
Marketing start
2021-04-20
Substance
METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength
2 g/30.6mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

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
A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20
A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212396-001AP
A212396-002AP
A212396-003AP
A212396-004AP
A212396-005AP

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 5 · 165 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-001METHYLPREDNISOLONE SODIUM SUCCINATEEQ 40MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-002METHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-003METHYLPREDNISOLONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-004METHYLPREDNISOLONE SODIUM SUCCINATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-005METHYLPREDNISOLONE SODIUM SUCCINATEEQ 2GM BASE/VIALINJECTABLE / INJECTIONAP2021-04-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212396-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212396-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212396-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212396-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212396-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212396-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212396-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212396-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212396-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212396-005AP15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone Sodium Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE SODIUM SUCCINATE2 g/30.6mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LEC9GKY20KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311659Internal RxNorm lookup
314099Internal RxNorm lookup
1357886Internal RxNorm lookup
1743704Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77a8d96c-37df-4f3a-9757-b2d4131ff82bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82094-405-01Methylprednisolone Sodium Succinate30.6 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,30.66
82094-405-50Methylprednisolone Sodium Succinate1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82094-405METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TIANJIN KINGYORK PHARMACEUTICALS CO., LTD]5Current NDC, Legacy NDC, 2 package rows20240809_77a8d96c-37df-4f3a-9757-b2d4131ff82b.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
METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEHF Acquisition Co LLC, DBA HealthFirst559427ac-9fc6-96f5-e063-6294a90a0b302026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.f339882f-c380-4022-bdcd-94556a7926aa2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONETianjin Kingyork Pharmaceuticals Co., Ltd77a8d96c-37df-4f3a-9757-b2d4131ff82b2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396
ndc (product): 82094-405
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEDr. Reddy's Laboratories Inc738753c7-507d-4881-5194-02dd7597768b2024-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212396
application number: ANDA212396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314099methylPREDNISolone 62.5 MG/ML Injectable SolutionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylPREDNISolone sodium succinate 125 MG InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylPREDNISolone sodium succinate 2 GM InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylPREDNISolone sodium succinate 40 MG InjectionPSN77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylprednisolone 125 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylprednisolone 2000 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylprednisolone 40 MG InjectionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
314099methylprednisolone 62.5 MG/ML Injectable SolutionSCD77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1743704methylprednisolone (as methylprednisolone sodium succinate) 125 MG InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
1357886methylprednisolone (as methylprednisolone sodium succinate) 2 GM InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
311659methylprednisolone (as methylprednisolone sodium succinate) 40 MG InjectionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6
314099methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable SolutionSY77a8d96c-37df-4f3a-9757-b2d4131ff82b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82094-405-018209404050130.6 mL in 1 VIAL30.6 mlHistorical
82094-405-50820940405501 VIAL in 1 CARTON (82094-405-50) / 30.6 mL in 1 VIAL (82094-405-01) 1 vial2021-04-200000-00-00NoNoCurrent