Home NDC 67457-997-40 Mitomycin
Product NDC 67457-997
Requested package NDC 67457-997-40
11-digit product format 674570997
Labeler code 67457
Product ID 67457-997_f5c057dc-8eb5-4c53-99aa-3c5a207dff14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mitomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA203386
Marketing category ANDA
Marketing start 2020-08-28
Marketing end 0000-00-00
Substance MITOMYCIN
Active strength 40 mg/80mL
Pharmacologic classes Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203386-001 MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203386-001 AP
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 · 41 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 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203386-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mitomycin MITOMYCIN Archis Pharma LLC 2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f 2023-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203386 application number: ANDA203386
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67457-997-40 67457099740 1 VIAL in 1 CARTON (67457-997-40) > 80 mL in 1 VIAL 1 vial 2020-08-28 0000-00-00 No No Current