Inactive ingredients by manufacturer

Lumacaftor and Ivacaftor inactive ingredients by manufacturer

Wondering whether your Lumacaftor and Ivacaftor 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 Lumacaftor and Ivacaftor 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 2 of the 5 current Lumacaftor and Ivacaftor products on the market today, from 1 company listing it with the FDA, and lined them up side by side. 3 are still being read and will appear on a later visit.

Ask about your bottle

Is there something in your Lumacaftor and Ivacaftor? 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 Lumacaftor and Ivacaftor products list lactose, a gluten source, soy, dyes or gelatin?

  1. LactoseNo checked product

    No checked Lumacaftor and Ivacaftor product lists lactose.

  2. Wheat or gluten sourceNo checked product

    No checked Lumacaftor and Ivacaftor product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Lumacaftor and Ivacaftor product lists soy.

  4. Synthetic dyesDiffers by manufacturer

    1 of 2 checked products list synthetic dyes; 1 does not. See the products

    Does not list it Vertex
    Lists it Vertex
  5. GelatinNo checked product

    No checked Lumacaftor and Ivacaftor product lists gelatin.

Also listed by some products: Titanium dioxide 1 of 2 Carmine or shellac 1 of 2 Propylene glycol 1 of 2 PEG or polysorbate 1 of 2

Find a version without it

Every current Lumacaftor and Ivacaftor product and what its label lists

Hide products that list:

ProductListsInactive ingredients on the label
Vertex Pharmaceuticals Incorporated 5 products
LUMACAFTOR 75 mg/1; IVACAFTOR 94 mg oral powderNDC 51167-0122-01 Still being read Not read yet
LUMACAFTOR 100 mg/1; IVACAFTOR 125 mg oral powderNDC 51167-0900-01 None of these listed
Show 5 ingredients

CROSCARMELLOSE SODIUM, HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MPA.S), MICROCRYSTALLINE CELLULOSE, POVIDONE, UNSPECIFIED, SODIUM LAURYL SULFATE
LUMACAFTOR 150 mg/1; IVACAFTOR 188 mg oral powderNDC 51167-0500-02 Still being read Not read yet
LUMACAFTOR 100 mg/1; IVACAFTOR 125 mg tabletNDC 51167-0700-02 Synthetic dyes Titanium dioxide Carmine or shellac Propylene glycol Polyethylene glycol or polysorbate
Show 17 ingredients

AMMONIA, CARMINIC ACID, CROSCARMELLOSE SODIUM, FD&C Blue No. 1, FD&C Blue No. 2, FERROSOFERRIC OXIDE, HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MPA.S), MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL 3350, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED, PROPYLENE GLYCOL, SHELLAC, SODIUM LAURYL SULFATE, TALC, TITANIUM DIOXIDE
LUMACAFTOR 200 mg/1; IVACAFTOR 125 mg tabletNDC 51167-0809-01 Still being read Not read yet

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.

Lumacaftor and Ivacaftor without synthetic dyes

Synthetic dyes: FD&C or D&C colorants and their aluminum lakes. 1 of 2 checked products list synthetic dyes; 1 does not.

Does not list synthetic dyes

Lists synthetic dyes

Lumacaftor and Ivacaftor without titanium dioxide

Titanium dioxide: A white colorant some people choose to avoid. 1 of 2 checked products list titanium dioxide; 1 does not.

Does not list titanium dioxide

Lists titanium dioxide

Lumacaftor and Ivacaftor without carmine or shellac

Carmine or shellac: insect-derived red colorant or coating glaze. 1 of 2 checked products list carmine or shellac; 1 does not.

Does not list carmine or shellac

Lists carmine or shellac

Lumacaftor and Ivacaftor without propylene glycol

Propylene glycol: A solvent in liquids and capsules; a concern in kidney disease, for infants, and at high doses. 1 of 2 checked products list propylene glycol; 1 does not.

Does not list propylene glycol

Lists propylene glycol

Lumacaftor and Ivacaftor without polyethylene glycol or polysorbate

Polyethylene glycol or polysorbate: PEG, macrogol or polysorbate; a rare cause of allergic reactions. 1 of 2 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 Lumacaftor and Ivacaftor product suits you →

Common questions about Lumacaftor and Ivacaftor inactive ingredients

Is Lumacaftor and Ivacaftor gluten-free?
This page cannot certify any Lumacaftor and Ivacaftor product gluten-free; it reports what each label declares. Of the 2 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 Lumacaftor and Ivacaftor contain lactose?
No checked Lumacaftor and Ivacaftor product lists lactose on its label. 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 Lumacaftor and Ivacaftor contain soy?
No checked Lumacaftor and Ivacaftor 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 Lumacaftor and Ivacaftor?
1 of 2 checked Lumacaftor and Ivacaftor products list a synthetic dye (an FD&C or D&C colorant); 1 does not: Vertex (LUMACAFTOR 100 mg/1; IVACAFTOR 125 mg oral powder). Colorants often differ by strength within one company's line, so compare the lists above strength by strength.
Does Lumacaftor and Ivacaftor contain gelatin?
No checked Lumacaftor and Ivacaftor 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 Lumacaftor and Ivacaftor 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 Lumacaftor and Ivacaftor 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 Lumacaftor and Ivacaftor guide