dacarbazine

Generic: dacarbazine

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dacarbazine
Generic Name dacarbazine
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dacarbazine 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-127
Product ID 63323-127_04644165-06c9-4a55-a026-a529d824cc90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075371
Listing Expiration 2026-12-31
Marketing Start 2001-09-07

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 63323127
Hyphenated Format 63323-127

Supplemental Identifiers

RxCUI
1731338 1731340
UPC
0363323128005 0363323127008
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 ANDA075371 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)
source: ndc

Packages (1)

63323-127-10 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)

Ingredients (1)

dacarbazine (10 mg/mL)

Linked Drug Pages (1)

Dacarbazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "04644165-06c9-4a55-a026-a529d824cc90", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0363323128005", "0363323127008"], "unii": ["7GR28W0FJI"], "rxcui": ["1731338", "1731340"], "spl_set_id": ["b6b97e41-5f15-498c-abfb-d8443ea4d216"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-127-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-127-00)", "package_ndc": "63323-127-10", "marketing_start_date": "20010907"}], "brand_name": "Dacarbazine", "product_id": "63323-127_04644165-06c9-4a55-a026-a529d824cc90", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "63323-127", "generic_name": "DACARBAZINE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dacarbazine", "active_ingredients": [{"name": "DACARBAZINE", "strength": "10 mg/mL"}], "application_number": "ANDA075371", "marketing_category": "ANDA", "marketing_start_date": "20010907", "listing_expiration_date": "20261231"}