dacarbazine

Generic: dacarbazine

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dacarbazine
Generic Name dacarbazine
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dacarbazine 200 mg/20mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-174
Product ID 71288-174_94e81c40-cf9b-45fa-a396-044196081d48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075259
Listing Expiration 2026-12-31
Marketing Start 2024-04-22

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288174
Hyphenated Format 71288-174

Supplemental Identifiers

RxCUI
1731338
UNII
7GR28W0FJI
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dacarbazine (source: ndc)
Generic Name dacarbazine (source: ndc)
Application Number ANDA075259 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20)
source: ndc

Packages (1)

71288-174-21 10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21) / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20)

Ingredients (1)

dacarbazine (200 mg/20mL)

Linked Drug Pages (1)

Dacarbazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "94e81c40-cf9b-45fa-a396-044196081d48", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["7GR28W0FJI"], "rxcui": ["1731338"], "spl_set_id": ["64037f45-6245-49f0-9ae8-18d75753ae1f"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (71288-174-21)  / 20 mL in 1 VIAL, SINGLE-USE (71288-174-20)", "package_ndc": "71288-174-21", "marketing_start_date": "20240422"}], "brand_name": "Dacarbazine", "product_id": "71288-174_94e81c40-cf9b-45fa-a396-044196081d48", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "71288-174", "generic_name": "Dacarbazine", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dacarbazine", "active_ingredients": [{"name": "DACARBAZINE", "strength": "200 mg/20mL"}], "application_number": "ANDA075259", "marketing_category": "ANDA", "marketing_start_date": "20240422", "listing_expiration_date": "20261231"}