Home NDC 49771-002 Mitosol
Product NDC 49771-002
11-digit product format 497710002
Labeler code 49771
Product ID 49771-002_ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mitomycin
Dosage form KIT
Labeler Mobius Therapeutics LLC
Application NDA022572
Marketing category NDA
Marketing start 2012-02-08
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 N022572-001 MITOSOL MITOMYCIN 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022572-001 8186511 2026-07-19 Drug product 2012-06-25 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 N022572-001 9649428 2029-05-21 U-2095 2017-06-09
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 · 42 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 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 6 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 2680178bc6a6…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022572-001 ODE-21 2019-02-07 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022572-001 ODE-21 2019-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022572-001 ODE-21 2019-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022572-001 ODE-21 2019-02-07 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Mitosol
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1244553 Internal RxNorm lookup 1244558 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 49771-002-01 Mitosol 1 in 1 TRAY KIT 1 10 49771-002-03 Mitosol 3 in 1 CARTON KIT 3 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49771-002 MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250423_244002c6-c61d-43fe-9326-072797113979.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 · 1 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 49771-002-01 49771000201 1 in 1 TRAY Historical 49771-002-03 49771000203 3 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASS 3 tray 2012-02-08 0000-00-00 No No Current