FDA.reportPublic FDA data

RediTrex

Product NDC
69605-815
11-digit product format
696050815
Labeler code
69605
Product ID
69605-815_d4506622-932a-fec8-e053-2a95a90afa41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
CENEXI - BLA
Application
NDA210737
Marketing category
NDA
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
METHOTREXATE
Active strength
15 mg/.6mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210737-001REDITREXMETHOTREXATE7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-002REDITREXMETHOTREXATE10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-003REDITREXMETHOTREXATE12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-004REDITREXMETHOTREXATE15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-005REDITREXMETHOTREXATE17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-006REDITREXMETHOTREXATE20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-007REDITREXMETHOTREXATE22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27
N210737-008REDITREXMETHOTREXATE25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-001REDITREX7.5MG/0.3ML (7.5MG/0.3ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-002REDITREX10MG/0.4ML (10MG/0.4ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-003REDITREX12.5MG/0.5ML (12.5MG/0.5ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-004REDITREX15MG/0.6ML (15MG/0.6ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-005REDITREX17.5MG/0.7ML (17.5MG/0.7ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-006REDITREX20MG/0.8ML (20MG/0.8ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-007REDITREX22.5MG/ML (22.5MG/ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210737-008REDITREX25MG/1ML (25MG/1ML)SOLUTION / SUBCUTANEOUSRLD2019-11-27b8a1b40f171c…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69605-815-22696050815224 CARTON in 1 CASE (69605-815-22) > 1 SYRINGE in 1 CARTON (69605-815-11) > .6 mL in 1 SYRINGE4 carton2020-07-010000-00-00NoNoCurrent