Mitomycin

Product NDC: 16729-246
Requested package NDC: 16729-246-05
11-digit product format: 167290246
Labeler code: 16729
Product ID: 16729-246_aef282e1-cee2-406f-e053-2995a90a28af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mitomycin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Accord Healthcare Inc
Application: ANDA064144
Marketing category: ANDA
Marketing start: 2013-05-03
Marketing end: 0000-00-00
Substance: MITOMYCIN
Active strength: 5 mg/10mL
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16729-246	16729-246-05	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-002	MITOMYCIN	20MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-003	MITOMYCIN	40MG/VIAL	INJECTABLE / INJECTION	AP	RS	2009-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064144-001	MITOMYCIN	5MG/VIAL	INJECTABLE / INJECTION	AP	RS	1998-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064144-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064144-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064144-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064144-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064144-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064144-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064144-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064144-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064144-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064144-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064144-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064144-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064144-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064144-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064144-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064144-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064144-003	AP	1	`301d65b070ca…`
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-246-05	EA - Each	16729-246	1dc6c19a-b7fc-4b69-b5f3-731b2ed65d02	1	2013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MITOMYCIN	ACTIVE INGREDIENT	50SG953SK6	MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC]	1
MITOMYCIN	ACTIVE MOIETY	50SG953SK6	MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC]	1

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.

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
Mitomycin	MITOMYCIN	BluePoint Laboratories	aad9a9a0-7204-452a-8b9b-6d625c4ee021	2021-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064144 application number: ANDA064144

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-246-05	16729024605	1 VIAL in 1 CARTON (16729-246-05) > 10 mL in 1 VIAL	1 vial	2013-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MITOMYCIN FOR INJECTION USP, 5 mg/vial NOVAPLUS ®	Accord Healthcare Inc \| Intas Pharmaceuticals Limited	2023-01-19	HUMAN PRESCRIPTION DRUG LABEL	4