Home NDC 71288-174 Dacarbazine
Product NDC 71288-174
11-digit product format 712880174
Labeler code 71288
Product ID 71288-174_94e81c40-cf9b-45fa-a396-044196081d48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dacarbazine
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA075259
Marketing category ANDA
Marketing start 2024-04-22
Substance DACARBAZINE
Active strength 200 mg/20mL
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Dacarbazine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DACARBAZINE 200 mg/20mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731338 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71288-174-20 Dacarbazine 20 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, FOR SOLUTION 20 1 71288-174-21 Dacarbazine 10 in 1 CARTON INJECTION, POWDER, FOR SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-174 DACARBAZINE INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 1 Current NDC, 2 package rows 20240423_64037f45-6245-49f0-9ae8-18d75753ae1f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71288-174-20 71288017420 20 mL in 1 VIAL, SINGLE-USE 20 ml Historical 71288-174-21 71288017421 10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20) 2024-04-22 No No Current