Home NDC 0703-5075 Dacarbazine
Product NDC 0703-5075
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 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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 0703-5075-03 00703507503 10 VIAL, SINGLE-DOSE in 1 TRAY (0703-5075-03) > 20 mL in 1 VIAL, SINGLE-DOSE 1998-08-27 0000-00-00 No No Current