Home NDC 71335-2927 Mitomycin
Product NDC 71335-2927
11-digit product format 713352927
Labeler code 71335
Product ID 71335-2927_fbb00883-4ca9-4396-bf6d-f5f1a136c08f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mitomycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Bryant Ranch Prepack
Application ANDA202670
Marketing category ANDA
Marketing start 2022-03-11
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 43 .
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 A202670-001 MITOMYCIN MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 A202670-002 MITOMYCIN MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202670-001 MITOMYCIN 5MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202670-002 MITOMYCIN 20MG/VIAL INJECTABLE / INJECTION AP 2017-10-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1740894 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 71335-2927-1 Mitomycin 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 100 71335-2927-1 Mitomycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 100
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mitomycin MITOMYCIN Bryant Ranch Prepack 5f41676f-f687-47db-871c-35bbf2447a98 2025-11-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202670 application number: ANDA202670 ndc (product): 71335-2927 Mitomycin MITOMYCIN Bryant Ranch Prepack 799a06b1-7697-42a3-b31a-c9d621b34f6f 2025-03-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202670 application number: ANDA202670 Mitomycin MITOMYCIN Archis Pharma LLC cef5026c-8bc3-4428-a178-6effff4dcb3f 2023-09-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202670 application number: ANDA202670 Mitomycin MITOMYCIN Archis Pharma LLC 2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f 2023-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202670 application number: ANDA202670
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2927-1 71335292701 1 VIAL in 1 CARTON (71335-2927-1) / 10 mL in 1 VIAL 1 vial 2025-11-11 No No Current