Home NDC 65219-568 MITOMYCIN
Product NDC 65219-568
11-digit product format 652190568
Labeler code 65219
Product ID 65219-568_c8893d3b-e9e0-4ab1-8c6d-376a7f1037bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MITOMYCIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA216648
Marketing category ANDA
Marketing start 2023-01-15
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216648-001 MITOMYCIN MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216648-001 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.
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 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216648-001 MITOMYCIN 40MG/VIAL INJECTABLE / INJECTION AP 2022-11-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740898 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 65219-568-00 MITOMYCIN 80 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 80 1 65219-568-00 MITOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-568 MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20230115_bc937e3d-7167-49a5-b6b1-004b0f89d8c4.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 · 3 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 65219-568-00 65219056800 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSE 2023-01-15 No No Current