busulfan

Generic: busulfan

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

Drug Facts

Product Profile

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

busulfan 6 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-116
Product ID 71288-116_ebe3b619-0e7a-42fc-bb7b-f219b900597b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212127
Listing Expiration 2026-12-31
Marketing Start 2020-10-23

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 71288116
Hyphenated Format 71288-116

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 ANDA212127 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-116-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)
source: ndc

Packages (1)

71288-116-11 8 VIAL, SINGLE-DOSE in 1 CARTON (71288-116-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)

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": "ebe3b619-0e7a-42fc-bb7b-f219b900597b", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["6e68ab21-19bd-4b7e-b8d0-bf284d5af183"], "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": "8 VIAL, SINGLE-DOSE in 1 CARTON (71288-116-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-116-10)", "package_ndc": "71288-116-11", "marketing_start_date": "20201023"}], "brand_name": "Busulfan", "product_id": "71288-116_ebe3b619-0e7a-42fc-bb7b-f219b900597b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "71288-116", "generic_name": "Busulfan", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA212127", "marketing_category": "ANDA", "marketing_start_date": "20201023", "listing_expiration_date": "20261231"}