Home NDC 70518-4345 Methylprednisolone Sodium Succinate
Product NDC 70518-4345
11-digit product format 705184345
Labeler code 70518
Product ID 70518-4345_5af9a22c-7a5e-3849-e063-6294a90add7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Sodium Succinate
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA203125
Marketing category ANDA
Marketing start 2025-05-27
Substance METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength 125 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26
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 2 · 56 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 2026-09-14 22:38:34 2026-08 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203125-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203125-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE / INJECTION AP 2022-09-26 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Methylprednisolone Sodium Succinate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE SODIUM SUCCINATE 125 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70518-4345-0 Methylprednisolone Sodium Succinate 25 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 25 1 70518-4345-1 Methylprednisolone Sodium Succinate 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, FOR SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4345 METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [REMEDYREPACK INC.] 1 Current NDC, 2 package rows 20250529_ae524bdb-9fd0-49f9-802d-465a374c175b.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4345-0 70518434500 25 VIAL, SINGLE-DOSE in 1 CARTON (70518-4345-0) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70518-4345-1) 2025-05-27 No No Current 70518-4345-1 70518434501 1 in 1 VIAL, SINGLE-DOSE Historical