Home NDC 42023-240 Methylprednisolone Acetate
Product NDC 42023-240
11-digit product format 420230240
Labeler code 42023
Product ID 42023-240_9d6bd79b-4885-454e-b127-c5978e501024
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTERIAL; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler Endo USA, Inc.
Application ANDA214297
Marketing category ANDA
Marketing start 2022-06-30
Substance METHYLPREDNISOLONE ACETATE
Active strength 80 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A214297-001 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 A214297-002 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21
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 · 64 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 2026-02-19 14:30 UTC 2026-02 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214297-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2022-01-21 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214297-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2022-01-21 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42023-240-01 Methylprednisolone Acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 19 42023-240-01 Methylprednisolone Acetate 5 mL in 1 VIAL INJECTION, SUSPENSION 5 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-240 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [ENDO USA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20240913_631f7d3e-5620-4be3-b918-2f0d38a97890.zip
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 42023-240-01 42023024001 1 VIAL in 1 CARTON (42023-240-01) / 5 mL in 1 VIAL 1 vial 2022-06-30 0000-00-00 No No Current