Home NDC 68083-483 MITOMYCIN
Product NDC 68083-483
11-digit product format 680830483
Labeler code 68083
Product ID 68083-483_64496224-9cec-48bb-a750-db192dd7780c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MITOMYCIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA215687
Marketing category ANDA
Marketing start 2021-10-20
Substance MITOMYCIN
Active strength 5 mg/10mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215687-001 MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 A215687-002 MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 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 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215687-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A215687-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2021-10-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 5 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740894 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 68083-483-01 MITOMYCIN 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 3 68083-483-01 MITOMYCIN 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-483 MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] 3 Current NDC, Legacy NDC, 2 package rows 20211027_650d3024-b9a9-4018-8115-0951acfe3145.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 Units Marketing start Marketing end Sample Exclude flag Status 68083-483-01 68083048301 1 VIAL in 1 CARTON (68083-483-01) / 10 mL in 1 VIAL 1 vial 2021-10-20 0000-00-00 No No Current