Mitomycin

Product NDC: 72819-153
Requested package NDC: 72819-153-02
11-digit product format: 728190153
Labeler code: 72819
Product ID: 72819-153_fd60f15a-95d0-b4ae-e053-6394a90a355c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mitomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Archis Pharma LLC
Application: ANDA202670
Marketing category: ANDA
Marketing start: 2022-04-25
Substance: MITOMYCIN
Active strength: 20 mg/40mL
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.

Application-product, TE code table
Application-product	TE code
A202670-001	AP
A202670-002	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.

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202670-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202670-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202670-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202670-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202670-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202670-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202670-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202670-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202670-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202670-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202670-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202670-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202670-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202670-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202670-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202670-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202670-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202670-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202670-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202670-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202670-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202670-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202670-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202670-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202670-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202670-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202670-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202670-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202670-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202670-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202670-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202670-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202670-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202670-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202670-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202670-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202670-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202670-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202670-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202670-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mitomycin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MITOMYCIN	20 mg/40mL

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61a18a7f-d50a-4423-aa08-6a8f710ed5da	Product name	7	20250722
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
1f4d6d8c-234a-4bf6-b123-695584719ba0	Product name	1	20200728
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72819-153-02	Mitomycin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		2
72819-153-02	Mitomycin	40 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	40		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72819-153-02	EA - Each	72819-153	823b3f70-501e-4fd8-9c39-1c44bafa4e23	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72819-153	MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ARCHIS PHARMA LLC]	2	Current NDC, 2 package rows	20230606_2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f.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 · 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
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 ndc (package): 72819-153-02 ndc (product): 72819-153 ndc11 (package): 72819015302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50SG953SK6	MITOMYCIN	50-07-7	MITOMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1740900	mitoMYcin 20 MG Injection	PSN	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2
1740898	mitoMYcin 40 MG Injection	PSN	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2
1740894	mitoMYcin 5 MG Injection	PSN	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2
1740900	mitomycin 20 MG Injection	SCD	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2
1740898	mitomycin 40 MG Injection	SCD	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2
1740894	mitomycin 5 MG Injection	SCD	2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72819-153-02	72819015302	1 VIAL in 1 CARTON (72819-153-02) / 40 mL in 1 VIAL	1 vial	2022-04-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mitomycin for Injection, USP Rx only	Archis Pharma LLC \| Mylan Laboratories Limited - OTL	2023-06-05	HUMAN PRESCRIPTION DRUG LABEL	2