Mitomycin inactive ingredients by manufacturer
Wondering whether your Mitomycin 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 Mitomycin 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 28 of the 38 current Mitomycin products on the market today, from 14 companies listing it with the FDA, and lined them up side by side. 7 are still being read and will appear on a later visit. 3 labels have no inactive-ingredient list we could read, so those products cannot be compared.
Ask about your bottle
Is there something in your Mitomycin? 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 Mitomycin products list lactose, a gluten source, soy, dyes or gelatin?
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LactoseNo checked product
No checked Mitomycin product lists lactose.
-
Wheat or gluten sourceNo checked product
No checked Mitomycin product lists a wheat or gluten source.
-
SoyNo checked product
No checked Mitomycin product lists soy.
-
Synthetic dyesNo checked product
No checked Mitomycin product lists synthetic dyes.
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GelatinNo checked product
No checked Mitomycin product lists gelatin.
Also listed by some products: Sorbitol or mannitol 28 of 28
Find a version without it
Every current Mitomycin product and what its label lists
| Product | Lists | Inactive ingredients on the label |
|---|---|---|
| Accord BioPharma Inc. 2 products | ||
| 5 mg/10 mL injectionNDC 69448-0001-05 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 69448-0003-38 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Accord Healthcare, Inc. 3 products | ||
| 5 mg/10 mL injectionNDC 16729-0115-05 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 16729-0108-11 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 16729-0116-38 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Archis Pharma LLC 3 products | ||
| 5 mg/10 mL injectionNDC 72819-0152-05 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 72819-0153-02 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 72819-0154-04 | Still being read | Not read yet |
| BluePoint Laboratories 6 products | ||
| 5 mg/10 mL injectionNDC 68001-0615-36 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 5 mg/10 mL injectionNDC 68001-0389-36 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 68001-0616-77 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 68001-0390-77 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 68001-0617-79 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 68001-0391-79 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Bryant Ranch Prepack 2 products | ||
| 5 mg/10 mL injectionNDC 71335-2927-01 | Still being read | Not read yet |
| 5 mg/10 mL injectionNDC 72162-2464-02 | Still being read | Not read yet |
| Eugia US LLC 3 products | ||
| 5 mg/10 mL injectionNDC 55150-0450-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 55150-0451-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 55150-0452-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Fresenius Kabi USA, LLC 3 products | ||
| 5 mg/10 mL injectionNDC 65219-0564-20 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 65219-0566-20 | Still being read | Not read yet |
| 40 mg/80 mL injectionNDC 65219-0568-00 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Gland Pharma Limited 3 products | ||
| 5 mg/10 mL injectionNDC 68083-0483-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 20 mg/40 mL injectionNDC 68083-0484-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| 40 mg/80 mL injectionNDC 68083-0502-01 | Still being read | Not read yet |
| Hikma Pharmaceuticals USA Inc. 4 products | ||
| 20 mg injectionNDC 00143-9135-01 | Sorbitol or mannitol |
Show 3 ingredientsHYDROCHLORIC ACID, MANNITOL, SODIUM HYDROXIDE |
| 20 mg/40 mL injectionNDC 00143-9279-01 | Still being read | Not read yet |
| 40 mg injectionNDC 00143-9136-01 | Sorbitol or mannitol |
Show 3 ingredientsHYDROCHLORIC ACID, MANNITOL, SODIUM HYDROXIDE |
| 40 mg/80 mL injectionNDC 00143-9280-01 | Sorbitol or mannitol |
Show 1 ingredientMANNITOL |
| Meitheal Pharmaceuticals Inc. 3 products | ||
| 5 mg/10 mL injectionNDC 71288-0137-20 | Sorbitol or mannitol |
Show 1 ingredientmannitol |
| 20 mg/40 mL injectionNDC 71288-0138-50 | Sorbitol or mannitol |
Show 1 ingredientmannitol |
| 40 mg/80 mL injectionNDC 71288-0139-51 | Sorbitol or mannitol |
Show 1 ingredientmannitol |
| Mobius Therapeutics LLC 1 product | ||
| kitsNDC 49771-0002-03 | No inactive-ingredient list on the label | No list we could read |
| Sagent Pharmaceuticals 3 products | ||
| 5 mg/10 mL injectionNDC 25021-0250-20 | Sorbitol or mannitol |
Show 1 ingredientMannitol |
| 20 mg/40 mL injectionNDC 25021-0251-50 | Still being read | Not read yet |
| 40 mg/80 mL injectionNDC 25021-0252-51 | Sorbitol or mannitol |
Show 1 ingredientMannitol |
| UroGen Pharma, Inc 1 product | ||
| kitsNDC 72493-0106-03 | No inactive-ingredient list on the label | No list we could read |
| UroGen Pharma, Inc. 1 product | ||
| kitsNDC 72493-0103-03 | No inactive-ingredient list on the label | No list we could read |
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.
Mitomycin and sorbitol or mannitol
Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. Every checked Mitomycin product (28) lists sorbitol or mannitol.
Lists sorbitol or mannitol
- Accord BioPharma: 5 mg/10 mL injection, 40 mg/80 mL injection
- Accord Healthcare: 5 mg/10 mL injection, 20 mg/40 mL injection, 40 mg/80 mL injection
- Archis: 5 mg/10 mL injection, 20 mg/40 mL injection
- BluePoint: 5 mg/10 mL injection (NDC 68001-0615-36), 5 mg/10 mL injection (NDC 68001-0389-36), 20 mg/40 mL injection (NDC 68001-0616-77), 20 mg/40 mL injection (NDC 68001-0390-77), 40 mg/80 mL injection (NDC 68001-0617-79), 40 mg/80 mL injection (NDC 68001-0391-79)
- Eugia: 5 mg/10 mL injection, 20 mg/40 mL injection, 40 mg/80 mL injection
- Fresenius Kabi: 5 mg/10 mL injection, 40 mg/80 mL injection
- Gland: 5 mg/10 mL injection, 20 mg/40 mL injection
- Hikma: 20 mg injection, 40 mg injection, 40 mg/80 mL injection
- Meitheal: 5 mg/10 mL injection, 20 mg/40 mL injection, 40 mg/80 mL injection
- Sagent: 5 mg/10 mL injection, 40 mg/80 mL injection
At the pharmacy counter
How to use this at the pharmacy counter
- 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.
- 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.
- 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.
- 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.
Common questions about Mitomycin inactive ingredients
Is Mitomycin gluten-free?
Does Mitomycin contain lactose?
Does Mitomycin contain soy?
Is there a dye-free Mitomycin?
Does Mitomycin contain gelatin?
Why do the inactive ingredients differ between manufacturers?
Can my pharmacy give me a specific manufacturer's version?
How current is this list?
Sources: the products are the finished Mitomycin products in the FDA's current NDC directory (openFDA), as of October 5, 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 Mitomycin guide