Home NDC 0703-0031 Methylprednisolone Acetate
Product NDC 0703-0031
11-digit product format 007030031
Labeler code 0703
Product ID 0703-0031_322c6b28-132a-41e1-9b0e-ea50f615d24c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler Teva Parenteral Medicines, Inc.
Application ANDA040557
Marketing category ANDA
Marketing start 2005-03-08
Marketing end 0000-00-00
Substance METHYLPREDNISOLONE ACETATE
Active strength 40 mg/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040557-001 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 A040557-002 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23
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 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040557-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2005-02-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040557-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2005-02-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHYLPREDNISOLONE ACETATE ACTIVE INGREDIENT 43502P7F0P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 METHYLPREDNISOLONE ACTIVE MOIETY X4W7ZR7023 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 MIRIPIRIUM CHLORIDE INACTIVE INGREDIENT 3D6CWI0P23 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [TEVA PARENTERAL MEDICINES, INC.] 6 METHYLPREDNISOLONE ACETATE ACTIVE INGREDIENT 43502P7F0P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPREDNISOLONE ACETATE ACTIVE INGREDIENT 43502P7F0P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 METHYLPREDNISOLONE ACTIVE MOIETY X4W7ZR7023 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 METHYLPREDNISOLONE ACTIVE MOIETY X4W7ZR7023 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 MIRIPIRIUM CHLORIDE INACTIVE INGREDIENT 3D6CWI0P23 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 MYRISTYL-.GAMMA.-PICOLINIUM CHLORIDE INACTIVE INGREDIENT 3D6CWI0P23 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PROFICIENT RX LP] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
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 0703-0031-01 00703003101 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-0031-01) > 1 mL in 1 VIAL, SINGLE-DOSE 2005-03-08 0000-00-00 No No Current 0703-0031-04 00703003104 25 VIAL, SINGLE-DOSE in 1 TRAY (0703-0031-04) > 1 mL in 1 VIAL, SINGLE-DOSE 2005-03-08 0000-00-00 No No Current