Dacarbazine

Product NDC: 0703-5075
Requested package NDC: 0703-5075-01
11-digit product format: 007035075
Labeler code: 0703
Product ID: 0703-5075_eba1f8b2-278e-47f8-8e45-849d9d0bfcfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dacarbazine
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Teva Parenteral Medicines, Inc.
Application: ANDA075259
Marketing category: ANDA
Marketing start: 1998-08-27
Marketing end: 0000-00-00
Substance: DACARBAZINE
Active strength: 200 mg/20mL
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0703-5075	0703-5075-01	D	Discontinued by firm		2026-08-03

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 1.

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
A075259-001	DACARBAZINE	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22
A075259-002	DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075259-001	AP
A075259-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075259-001	DACARBAZINE	500MG/VIAL	INJECTABLE / INJECTION	AP	RS	2000-09-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075259-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP		1998-08-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075259-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075259-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075259-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075259-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075259-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075259-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075259-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075259-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075259-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075259-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075259-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075259-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075259-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075259-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075259-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075259-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075259-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075259-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075259-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075259-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075259-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075259-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075259-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075259-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075259-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075259-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075259-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075259-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075259-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075259-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075259-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075259-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075259-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075259-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075259-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075259-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075259-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075259-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075259-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075259-002	AP	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0703-5075-01	EA - Each	0703-5075	0ed037b9-9bc5-437a-9dca-47c010616824	1	2012-07-24
0703-5075-03	EA - Each	0703-5075	3ad6d3e3-f779-4864-8715-8242effb07f7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DACARBAZINE	ACTIVE INGREDIENT	7GR28W0FJI	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
DACARBAZINE	ACTIVE MOIETY	7GR28W0FJI	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.]	2

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dacarbazine	DACARBAZINE	Meitheal Pharmaceuticals Inc.	64037f45-6245-49f0-9ae8-18d75753ae1f	2024-03-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075259 application number: ANDA075259

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7GR28W0FJI	DACARBAZINE	4342-03-4	DACARBAZINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0703-5075-01	00703507501	1 VIAL, SINGLE-DOSE in 1 CARTON (0703-5075-01) > 20 mL in 1 VIAL, SINGLE-DOSE	1998-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dacarbazine for Injection, USP	Teva Parenteral Medicines, Inc.	2020-02-28	HUMAN PRESCRIPTION DRUG LABEL	13