Dacarbazine

Product NDC: 63323-127
11-digit product format: 633230127
Labeler code: 63323
Product ID: 63323-127_04644165-06c9-4a55-a026-a529d824cc90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DACARBAZINE
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA075371
Marketing category: ANDA
Marketing start: 2001-09-07
Substance: DACARBAZINE
Active strength: 10 mg/mL
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 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
A075371-001	DACARBAZINE	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27
A075371-002	DACARBAZINE	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075371-002	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	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075371-001	DACARBAZINE	100MG/VIAL	INJECTABLE / INJECTION		RS	1999-08-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075371-002	DACARBAZINE	200MG/VIAL	INJECTABLE / INJECTION	AP	RS	1999-08-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075371-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075371-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075371-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075371-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075371-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075371-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075371-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075371-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075371-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075371-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075371-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075371-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075371-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075371-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075371-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075371-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075371-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075371-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075371-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075371-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075371-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075371-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075371-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075371-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075371-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075371-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075371-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075371-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075371-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075371-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075371-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075371-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075371-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075371-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075371-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075371-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075371-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075371-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075371-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075371-002	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DACARBAZINE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7GR28W0FJI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731338	Internal RxNorm lookup
1731340	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
b6b97e41-5f15-498c-abfb-d8443ea4d216	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
21263ae2-912c-bf52-bf34-9ea80b3e11b9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-127-00	Dacarbazine	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	10		4
63323-127-10	Dacarbazine	10 in 1 TRAY	INJECTION, POWDER, FOR SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-127-00	EA - Each	63323-127	9030847d-b3da-4929-b2a5-df9cc6a4fae4	1	2023-10-16
63323-127-10	EA - Each	63323-127	4adc01d1-8f6e-429c-8a76-f572d71ddd53	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DACARBAZINE	ACTIVE INGREDIENT	7GR28W0FJI	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1
DACARBAZINE	ACTIVE MOIETY	7GR28W0FJI	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DACARBAZINE INJECTION, POWDER, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-127	DACARBAZINE (DACARBAZINE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC]	4	Current NDC, Legacy NDC, 2 package rows	20221029_b6b97e41-5f15-498c-abfb-d8443ea4d216.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dacarbazine	DACARBAZINE	Fresenius Kabi USA, LLC	b6b97e41-5f15-498c-abfb-d8443ea4d216	2022-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075371 application number: ANDA075371 ndc (product): 63323-127

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731340	dacarbazine 100 MG Injection	PSN	b6b97e41-5f15-498c-abfb-d8443ea4d216	4
1731338	dacarbazine 200 MG Injection	PSN	b6b97e41-5f15-498c-abfb-d8443ea4d216	4
1731340	dacarbazine 100 MG Injection	SCD	b6b97e41-5f15-498c-abfb-d8443ea4d216	4
1731338	dacarbazine 200 MG Injection	SCD	b6b97e41-5f15-498c-abfb-d8443ea4d216	4
1731338	dacarbazine (as dacarbazine citrate) 200 MG Injection	SY	b6b97e41-5f15-498c-abfb-d8443ea4d216	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-127-00	63323012700	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
63323-127-10	63323012710	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)		2001-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dacarbazine for Injection, USP	Fresenius Kabi USA, LLC	2022-10-20	HUMAN PRESCRIPTION DRUG LABEL	4