Home NDC 0143-9182 Methylprednisolone Sodium Succinate
Product NDC 0143-9182
11-digit product format 001439182
Labeler code 0143
Product ID 0143-9182_5ba132ce-e07c-46e3-afa5-800847136136
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Sodium Succinate
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA202691
Marketing category ANDA
Marketing start 2024-01-15
Substance METHYLPREDNISOLONE SODIUM SUCCINATE
Active strength 1 g/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16
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 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202691-001 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202691-002 METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP 2016-02-16 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE SODIUM SUCCINATE 1 g/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 314099 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 0143-9182-01 Methylprednisolone Sodium Succinate 1 in 1 VIAL, MULTI-DOSE INJECTION, POWDER, FOR SOLUTION 1 2 0143-9182-01 Methylprednisolone Sodium Succinate 1 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9182 METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, 2 package rows 20240319_060bcf13-ce9e-488c-ad43-9d66abb23b18.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 · 2 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 0143-9182-01 00143918201 1 VIAL, MULTI-DOSE in 1 CARTON (0143-9182-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE 2024-01-15 No No Current