Inactive ingredients by manufacturer

Busulfan inactive ingredients by manufacturer

Wondering whether your Busulfan has lactose, gluten, soy, a dye or gelatin in it? The medicine is the same, but the fillers, coatings and colors differ from one company to the next. This page shows what each Busulfan product's FDA label lists, so you can find a version that leaves out what you avoid and ask your pharmacist for it by its NDC.

We have read the FDA labels of 7 of the 9 current Busulfan products on the market today, from 8 companies listing it with the FDA, and lined them up side by side. 2 are still being read and will appear on a later visit.

Ask about your bottle

Is there something in your Busulfan? Ask in plain words.

Name the company, strength or the NDC on your bottle and the ingredient you avoid. The answer comes only from the FDA labels on this page.

Answers are drawn from the FDA label data on this page and checked against it. They are not medical advice: confirm with your pharmacist before relying on them.

The short answer

Which Busulfan products list lactose, a gluten source, soy, dyes or gelatin?

  1. LactoseDiffers by manufacturer

    1 of 7 checked products list lactose; 6 do not. See the products

    Does not list it Accord Healthcare Amneal Eugia Hospira Meitheal Sagent
    Lists it Waylis Therapeutics
  2. Wheat or gluten sourceNo checked product

    No checked Busulfan product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Busulfan product lists soy.

  4. Synthetic dyesNo checked product

    No checked Busulfan product lists synthetic dyes.

  5. GelatinNo checked product

    No checked Busulfan product lists gelatin.

Also listed by some products: Corn 1 of 7 Titanium dioxide 1 of 7 PEG or polysorbate 6 of 7

Find a version without it

Every current Busulfan product and what its label lists

Hide products that list:

ProductListsInactive ingredients on the label
Accord Healthcare, Inc 1 product
6 mg/mL injectionNDC 16729-0351-92 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-DIMETHYLACETAMIDE, POLYETHYLENE GLYCOL 400
Amneal Pharmaceuticals LLC 1 product
6 mg/mL injectionNDC 70121-1244-07 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-DIMETHYLACETAMIDE, POLYETHYLENE GLYCOL 400
Eugia US LLC 1 product
6 mg/mL injectionNDC 55150-0395-08 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-DIMETHYLACETAMIDE, POLYETHYLENE GLYCOL 400
Hospira, Inc. 1 product
6 mg/mL injectionNDC 00409-1112-01 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-DIMETHYLACETAMIDE, POLYETHYLENE GLYCOL 400
Meitheal Pharmaceuticals Inc. 2 products
6 mg/mL injectionNDC 71288-0116-11 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-Dimethylacetamide, POLYETHYLENE GLYCOL 400
6 mg/mL injectionNDC 71288-0158-96 Still being read Not read yet
Pharmascience Inc. 1 product
6 mg/mL injectionNDC 51817-0170-01 Still being read Not read yet
Sagent Pharmaceuticals 1 product
6 mg/mL injectionNDC 25021-0241-10 Polyethylene glycol or polysorbate
Show 2 ingredients

N,N-Dimethylacetamide, Polyethylene Glycol, unspecified
Waylis Therapeutics LLC 1 product
2 mg tabletNDC 80725-0620-25 Lactose Corn-derived Titanium dioxide
Show 6 ingredients

ANHYDROUS LACTOSE, HYPROMELLOSES, MAGNESIUM STEARATE, STARCH, CORN, TITANIUM DIOXIDE, TRIACETIN

A product with none of these listed is not certified to be without them: the label says what the manufacturer declared, and the source of a starch or a flavor is often not stated. The companies are the FDA's labelers, which include repackagers and distributors selling another company's product under their own label. The NDC opens the product's own page, with the full label and its inactive-ingredient notes.

Busulfan without lactose

Lactose: milk sugar; a concern with lactose intolerance or a milk allergy. 1 of 7 checked products list lactose; 6 do not.

Does not list lactose

Lists lactose

Busulfan without corn-derived ingredients

Corn-derived: corn starch, maize or corn syrup; a concern with corn allergy. 1 of 7 checked products list corn-derived ingredients; 6 do not.

Does not list corn-derived ingredients

Lists corn-derived ingredients

Busulfan without titanium dioxide

Titanium dioxide: A white colorant some people choose to avoid. 1 of 7 checked products list titanium dioxide; 6 do not.

Does not list titanium dioxide

Lists titanium dioxide

Busulfan without polyethylene glycol or polysorbate

Polyethylene glycol or polysorbate: PEG, macrogol or polysorbate; a rare cause of allergic reactions. 6 of 7 checked products list polyethylene glycol or polysorbate; 1 does not.

Does not list polyethylene glycol or polysorbate

Lists polyethylene glycol or polysorbate

At the pharmacy counter

How to use this at the pharmacy counter

  1. Pick the company whose list suits you and copy the NDC from the table. Many pharmacies order from wholesalers that carry several companies' versions and can request a particular one if you ask before the prescription is filled; some buy from one contracted source only, and a few insurance plans cover only certain NDCs, so ask the pharmacist to check.
  2. Treat "does not list" as exactly that. The label is what the manufacturer declared; a flavor or a starch may have an unstated source, and lines change. For celiac disease or a serious allergy, ask the manufacturer's medical information line for a written statement about the lot you have.
  3. Check the bottle each refill. A different company usually means a different shape, color and inactive-ingredient list; the pharmacist can tell you who made it, and the two-NDC comparison shows the difference line by line.
  4. If you need one company's version kept constant, ask your prescriber to write that company or the NDC on the prescription and tell the pharmacy you need it held. Rules vary by state and plan, so confirm with the pharmacist.
Ask Dr. Staiger which Busulfan product suits you →

Common questions about Busulfan inactive ingredients

Is Busulfan gluten-free?
This page cannot certify any Busulfan product gluten-free; it reports what each label declares. Of the 7 products checked, none lists a wheat, barley, rye or gluten ingredient, and none lists a starch without a stated source. If you have celiac disease, ask the manufacturer's medical information line for a written gluten statement for the lot you have.
Does Busulfan contain lactose?
1 of 7 checked Busulfan products list lactose; 6 do not: Accord Healthcare (6 mg/mL injection), Amneal (6 mg/mL injection), Eugia (6 mg/mL injection) and Hospira (6 mg/mL injection) and 2 other companies. The lactose in a tablet or capsule is a small amount, but people with a milk allergy or a strong intolerance often prefer a version that does not list it.
Does Busulfan contain soy?
No checked Busulfan product lists a soy ingredient (soybean oil or soy lecithin) on its label. Soy lecithin is the usual form and the amount is small, but people with a soy allergy often prefer a version that does not list it.
Is there a dye-free Busulfan?
No checked Busulfan product lists a synthetic dye (an FD&C or D&C colorant) on its label. Colorants often differ by strength within one company's line, so compare the lists above strength by strength.
Does Busulfan contain gelatin?
No checked Busulfan product lists gelatin on its label. Gelatin is usually bovine or porcine and the label rarely says which; for kosher, halal or vegetarian needs, ask the manufacturer.
Why do the inactive ingredients differ between manufacturers?
A generic must match the brand's active ingredient, strength, dose form and how it is absorbed; its fillers, binders, coatings and colorants are the manufacturer's own choice. That is why one Busulfan product can list lactose and a dye while another from a different company lists neither.
Can my pharmacy give me a specific manufacturer's version?
Often, if you ask before the prescription is filled: many pharmacies order from wholesalers that carry several companies' versions and can request a particular one. Some pharmacies buy a generic from one contracted source only, and a few insurance plans cover only certain NDCs, so ask the pharmacist to check. Give them the NDC from this page; the company name alone is often enough.
How current is this list?
The products are the ones in the FDA's current NDC directory as of October 6, 2026, and each inactive-ingredient list is the manufacturer's FDA label as our label sync last read it. Formulations change, so check the label on your own bottle and ask your pharmacist if a refill looks different.

Sources: the products are the finished Busulfan products in the FDA's current NDC directory (openFDA), as of October 6, 2026; each inactive-ingredient list is the manufacturer's FDA Structured Product Label via DailyMed, as our label sync last read it. The concern groups are HelloPharmacist's classification of the names the label declares. Educational information only, not medical advice; confirm with your pharmacist before relying on a list. ← Back to the Busulfan guide