busulfan

Generic: busulfan

Labeler: accord healthcare, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler accord healthcare, inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Accord Healthcare, Inc

Identifiers & Regulatory

Product NDC 16729-351
Product ID 16729-351_0e2ef789-efb4-8395-e063-6294a90a9145
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210148
Listing Expiration 2026-12-31
Marketing Start 2019-07-22

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 16729351
Hyphenated Format 16729-351

Supplemental Identifiers

RxCUI
253113
UPC
0316729351034
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 ANDA210148 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)
source: ndc

Packages (1)

16729-351-92 8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)

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": "0e2ef789-efb4-8395-e063-6294a90a9145", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0316729351034"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["fe0ddd44-ef02-4827-b164-7fcbb45bcc1b"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Accord Healthcare, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92)  / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)", "package_ndc": "16729-351-92", "marketing_start_date": "20190722"}], "brand_name": "Busulfan", "product_id": "16729-351_0e2ef789-efb4-8395-e063-6294a90a9145", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "16729-351", "generic_name": "busulfan", "labeler_name": "Accord Healthcare, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA210148", "marketing_category": "ANDA", "marketing_start_date": "20190722", "listing_expiration_date": "20261231"}