Home NDC 66220-822 RediTrex
Product NDC 66220-822
11-digit product format 662200822
Labeler code 66220
Product ID 66220-822_806b78db-9e7c-4a88-abd2-86a939f95986
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methotrexate
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler Cumberland Pharmaceuticals Inc.
Application NDA210737
Marketing category NDA
Marketing start 2020-07-01
Marketing end 0000-00-00
Substance METHOTREXATE
Active strength 23 mg/.9mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66220-822-22 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66220-822-22 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66220-822-22 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66220-822-22 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66220-822-22 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66220-822-22 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66220-822-22 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66220-822-22 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66220-822-22 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66220-822-22 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66220-822-22 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66220-822-22 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210737-001 REDITREX METHOTREXATE 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-002 REDITREX METHOTREXATE 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-003 REDITREX METHOTREXATE 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-004 REDITREX METHOTREXATE 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-005 REDITREX METHOTREXATE 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-006 REDITREX METHOTREXATE 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-007 REDITREX METHOTREXATE 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 N210737-008 REDITREX METHOTREXATE 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27
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 8 · 304 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 N210737-001 REDITREX 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-002 REDITREX 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-003 REDITREX 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-004 REDITREX 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-005 REDITREX 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-006 REDITREX 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-007 REDITREX 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210737-008 REDITREX 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-001 REDITREX 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-002 REDITREX 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-003 REDITREX 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-004 REDITREX 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-005 REDITREX 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-006 REDITREX 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-007 REDITREX 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210737-008 REDITREX 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210737-001 REDITREX 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-002 REDITREX 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-003 REDITREX 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-004 REDITREX 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-005 REDITREX 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-006 REDITREX 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-007 REDITREX 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210737-008 REDITREX 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-001 REDITREX 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-002 REDITREX 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-003 REDITREX 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-004 REDITREX 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-005 REDITREX 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-006 REDITREX 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-007 REDITREX 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210737-008 REDITREX 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-001 REDITREX 7.5MG/0.3ML (7.5MG/0.3ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-002 REDITREX 10MG/0.4ML (10MG/0.4ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-003 REDITREX 12.5MG/0.5ML (12.5MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-004 REDITREX 15MG/0.6ML (15MG/0.6ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-005 REDITREX 17.5MG/0.7ML (17.5MG/0.7ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-006 REDITREX 20MG/0.8ML (20MG/0.8ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-007 REDITREX 22.5MG/ML (22.5MG/ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210737-008 REDITREX 25MG/1ML (25MG/1ML) SOLUTION / SUBCUTANEOUS RLD 2019-11-27 b8a1b40f171c…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66220-822-22 66220082222 4 CARTON in 1 CASE (66220-822-22) > 1 SYRINGE in 1 CARTON (66220-822-11) > .9 mL in 1 SYRINGE 4 carton 2020-07-01 0000-00-00 No No Current