busulfan

Generic: busulfan

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1244
Product ID 70121-1244_973e7d91-192a-4dea-9056-4f98c37cdc6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209580
Listing Expiration 2026-12-31
Marketing Start 2017-12-18

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 701211244
Hyphenated Format 70121-1244

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 ANDA209580 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)
source: ndc

Packages (1)

70121-1244-7 8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)

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": "973e7d91-192a-4dea-9056-4f98c37cdc6f", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["ac9448da-37ad-4609-9aef-eedf8be0f69c"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7)  / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)", "package_ndc": "70121-1244-7", "marketing_start_date": "20171218"}], "brand_name": "Busulfan", "product_id": "70121-1244_973e7d91-192a-4dea-9056-4f98c37cdc6f", "dosage_form": "INJECTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "70121-1244", "generic_name": "Busulfan", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA209580", "marketing_category": "ANDA", "marketing_start_date": "20171218", "listing_expiration_date": "20261231"}