busulfan

Generic: busulfan

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-241
Product ID 25021-241_673100ef-2b51-4ba2-af5c-fe7c52220636
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207050
Listing Expiration 2026-12-31
Marketing Start 2017-05-15

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 25021241
Hyphenated Format 25021-241

Supplemental Identifiers

RxCUI
253113
UNII
G1LN9045DK
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 busulfan (source: ndc)
Generic Name busulfan (source: ndc)
Application Number ANDA207050 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL in 1 CARTON (25021-241-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-241-10 8 VIAL in 1 CARTON (25021-241-10) / 10 mL in 1 VIAL

Ingredients (1)

busulfan (6 mg/mL)

Linked Drug Pages (1)

Busulfan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "673100ef-2b51-4ba2-af5c-fe7c52220636", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["086a715e-4958-4bb5-9ebd-86171e6b6203"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL in 1 CARTON (25021-241-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-241-10", "marketing_start_date": "20170515"}], "brand_name": "Busulfan", "product_id": "25021-241_673100ef-2b51-4ba2-af5c-fe7c52220636", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "25021-241", "generic_name": "Busulfan", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA207050", "marketing_category": "ANDA", "marketing_start_date": "20170515", "listing_expiration_date": "20261231"}