dacarbazine

Generic: dacarbazine

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

Drug Facts

Product Profile

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

dacarbazine 200 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9245
Product ID 0143-9245_bbbf119e-26f4-46c1-ba80-de927e51c566
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075812
Listing Expiration 2026-12-31
Marketing Start 2001-08-08

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 01439245
Hyphenated Format 0143-9245

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 ANDA075812 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9245-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9245-01)
source: ndc

Packages (1)

0143-9245-10 10 VIAL in 1 CARTON (0143-9245-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9245-01)

Ingredients (1)

dacarbazine (200 mg/1)

Linked Drug Pages (1)

Dacarbazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "bbbf119e-26f4-46c1-ba80-de927e51c566", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["7GR28W0FJI"], "rxcui": ["1731338"], "spl_set_id": ["0d81315c-7021-4091-b703-ad135390c936"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9245-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9245-01)", "package_ndc": "0143-9245-10", "marketing_start_date": "20010808"}], "brand_name": "Dacarbazine", "product_id": "0143-9245_bbbf119e-26f4-46c1-ba80-de927e51c566", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "0143-9245", "generic_name": "Dacarbazine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dacarbazine", "active_ingredients": [{"name": "DACARBAZINE", "strength": "200 mg/1"}], "application_number": "ANDA075812", "marketing_category": "ANDA", "marketing_start_date": "20010808", "listing_expiration_date": "20261231"}