Home NDC 55150-452 MITOMYCIN
Product NDC 55150-452
11-digit product format 551500452
Labeler code 55150
Product ID 55150-452_f5a010cf-5954-4e6d-acfa-fb414efdf471
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MITOMYCIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Eugia US LLC
Application ANDA216732
Marketing category ANDA
Marketing start 2023-10-30
Substance MITOMYCIN
Active strength 40 mg/80mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216732-001 MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION 2023-10-30 A216732-002 MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION 2023-10-30 A216732-003 MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION 2023-10-30
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 · 60 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 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION 2023-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION 2023-10-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION 2023-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION 2023-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION 2023-10-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION 2023-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION 2023-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION 2023-10-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION 2023-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216732-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216732-003 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216732-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2023-10-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base MITOMYCIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MITOMYCIN 40 mg/80mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50SG953SK6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740894 Internal RxNorm lookup 1740898 Internal RxNorm lookup 1740900 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 55150-452-01 MITOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 55150-452-01 MITOMYCIN 80 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 80 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-452 MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] 1 Current NDC, 2 package rows 20231101_f5a010cf-5954-4e6d-acfa-fb414efdf471.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 · 2 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 55150-452-01 55150045201 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-452-01) / 80 mL in 1 VIAL, SINGLE-DOSE 2023-10-30 No No Current