MUTAMYCIN

Product NDC: 69448-002
11-digit product format: 694480002
Labeler code: 69448
Product ID: 69448-002_55ab68d0-c46a-2f41-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mitomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Accord BioPharma Inc.
Application: ANDA064144
Marketing category: ANDA
Marketing start: 2017-07-25
Marketing end: 0000-00-00
Substance: MITOMYCIN
Active strength: 20 mg/40mL
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69448-002		D	Discontinued by firm		2026-10-12
excluded package	package	69448-002	69448-002-11	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69448-002-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69448-002-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69448-002-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69448-002-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69448-002-11	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064144-001	MITOMYCIN	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30
A064144-002	MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30
A064144-003	MITOMYCIN	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A064144-001	AP
A064144-002	AP
A064144-003	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 4 · 129 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	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP		1998-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION			1998-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION			1998-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 127 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064144-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064144-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064144-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064144-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064144-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064144-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064144-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064144-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064144-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064144-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064144-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064144-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064144-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064144-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064144-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064144-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064144-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064144-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064144-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064144-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064144-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064144-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064144-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064144-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064144-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064144-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064144-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064144-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064144-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064144-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064144-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064144-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064144-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064144-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064144-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064144-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064144-001	AP	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
61a18a7f-d50a-4423-aa08-6a8f710ed5da	Product name	7	20250722
1f4d6d8c-234a-4bf6-b123-695584719ba0	Product name	1	20200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69448-002-11	MUTAMYCIN	40 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	40		3
69448-002-11	MUTAMYCIN	1 in 1 BOX, UNIT-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69448-002-11	EA - Each	69448-002	d8f16665-ad1f-4777-80dc-d09857335565	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69448-002	MUTAMYCIN (MITOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD BIOPHARMA INC.]	3	Legacy NDC, 2 package rows	20250315_cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mitomycin	MITOMYCIN	Accord Healthcare, Inc.	ff676355-313d-4575-8f2f-e4a1e9527477	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144
MUTAMYCIN	MITOMYCIN	Accord BioPharma Inc.	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144 ndc (product): 69448-002

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	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1740898	mitoMYcin 40 MG Injection	PSN	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1740894	mitoMYcin 5 MG Injection	PSN	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812480	MUTAMYCIN 20 MG Injection	PSN	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812482	MUTAMYCIN 40 MG Injection	PSN	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812484	MUTAMYCIN 5 MG Injection	PSN	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812480	mitomycin 20 MG Injection [Mutamycin]	SBD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812482	mitomycin 40 MG Injection [Mutamycin]	SBD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812484	mitomycin 5 MG Injection [Mutamycin]	SBD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1740900	mitomycin 20 MG Injection	SCD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1740898	mitomycin 40 MG Injection	SCD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1740894	mitomycin 5 MG Injection	SCD	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812480	Mutamycin 20 MG Injection	SY	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812482	Mutamycin 40 MG Injection	SY	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3
1812484	Mutamycin 5 MG Injection	SY	cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69448-002-11	69448000211	1 VIAL in 1 BOX, UNIT-DOSE (69448-002-11) > 40 mL in 1 VIAL	1 vial	2017-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MUTAMYCIN ® (Mitomycin) FOR INJECTION USP, 5 mg/vial, 20 mg/vial and 40 mg/vial	Accord BioPharma Inc. \| Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-03-12	HUMAN PRESCRIPTION DRUG LABEL	3