Home NDC 70121-1609-5 Methylprednisolone acetate
Product NDC 70121-1609
Requested package NDC 70121-1609-5
11-digit product format 701211609
Labeler code 70121
Product ID 70121-1609_924543a3-d04f-4c44-a2ee-008301b1f620
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone acetate
Dosage form INJECTION, SUSPENSION
Route INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler Amneal Pharmaceuticals LLC
Application ANDA216502
Marketing category ANDA
Marketing start 2023-11-10
Substance METHYLPREDNISOLONE ACETATE
Active strength 40 mg/mL
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 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 A216502-001 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 A216502-002 METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03
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.
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 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216502-001 METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE / INJECTION AB 2023-11-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216502-002 METHYLPREDNISOLONE ACETATE 80MG/ML INJECTABLE / INJECTION AB 2023-11-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methylprednisolone acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLPREDNISOLONE ACETATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 43502P7F0P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1358610 Internal RxNorm lookup 1358617 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 70121-1609-1 Methylprednisolone acetate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 10 10 70121-1609-1 Methylprednisolone acetate 1 in 1 CARTON INJECTION, SUSPENSION 1 10 70121-1609-5 Methylprednisolone acetate 10 mL in 1 VIAL, MULTI-DOSE INJECTION, SUSPENSION 10 10 70121-1609-5 Methylprednisolone acetate 25 in 1 CARTON INJECTION, SUSPENSION 25 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1609 METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC] 7 Current NDC, 4 package rows 20240805_de12f38c-ffa1-4d62-b9cb-238a263f6fea.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 Sample Exclude flag Status 70121-1609-5 70121160905 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5) / 10 mL in 1 VIAL, MULTI-DOSE 2023-11-10 No No Current