Home NDC 63323-265 Methylprednisolone Sodium Succinate
Product NDC 63323-265
11-digit product format 633230265
Labeler code 63323
Product ID 63323-265_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 ANDA040612
Marketing category ANDA
Marketing start 2004-11-30
Substance METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength 1 g/16mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040612-001 AP
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 2 · 42 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 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040612-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2004-08-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 1 g/16mL
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 63323-265-30 Methylprednisolone Sodium Succinate 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 63323-265-30 Methylprednisolone Sodium Succinate 16 mL in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 16 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 63323-265 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 Marketing start Marketing end Sample Exclude flag Status 63323-265-30 63323026530 1 VIAL, MULTI-DOSE in 1 CARTON (63323-265-30) / 16 mL in 1 VIAL, MULTI-DOSE 2004-11-30 0000-00-00 No No Current