Home NDC 63323-255 Methylprednisolone Sodium Succinate
Product NDC 63323-255
11-digit product format 633230255
Labeler code 63323
Product ID 63323-255_dc369096-3042-4942-9aeb-bbdf98f35bb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA040583
Marketing category ANDA
Marketing start 2004-11-30
Substance METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength 40 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63323-255-03 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63323-255-03 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63323-255-03 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63323-255-03 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63323-255-03 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63323-255-03 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63323-255-03 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63323-255-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63323-255-03 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63323-255-03 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63323-255-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63323-255-03 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040583-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040583-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2004-07-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methylprednisolone Sodium Succinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE SODIUM SUCCINATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LEC9GKY20K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311659 Internal RxNorm lookup 314099 Internal RxNorm lookup 1743704 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-255-01 Methylprednisolone Sodium Succinate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 7 63323-255-03 Methylprednisolone Sodium Succinate 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLPREDNISOLONE SODIUM SUCCINATE ACTIVE INGREDIENT LEC9GKY20K METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 METHYLPREDNISOLONE ACTIVE MOIETY X4W7ZR7023 METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM PHOSPHATE, MONOBASIC ANHYDROUS INACTIVE INGREDIENT KH7I04HPUU METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-255 METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20230509_c5d22210-73c6-4697-a267-75e243508642.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-255-01 63323025501 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 63323-255-03 63323025503 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-255-03) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-255-01) 2004-11-30 0000-00-00 No No Current