Inactive ingredients by manufacturer

Macitentan inactive ingredients by manufacturer

Wondering whether your Macitentan 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 Macitentan 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 13 of the 14 current Macitentan products on the market today, from 14 companies listing it with the FDA, and lined them up side by side. 1 is still being read and will appear on a later visit.

Ask about your bottle

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

  1. LactoseDiffers by manufacturer

    7 of 13 checked products list lactose; 6 do not. See the products

    Does not list it Apotex Laurus Novugen Sun Teva Torrent
    Lists it Alembic Pharmaceuticals Inc. Alembic Pharmaceuticals Limited Amneal Aurobindo Mylan Sandoz Zydus
  2. Wheat or gluten sourceNo checked product

    No checked Macitentan product lists a wheat or gluten source.

  3. SoyDiffers by manufacturer

    9 of 13 checked products list soy; 4 do not. See the products

    Does not list it Apotex Mylan Teva Zydus
    Lists it Alembic Pharmaceuticals Inc. Alembic Pharmaceuticals Limited Amneal Aurobindo Laurus Novugen Sandoz Sun Torrent
  4. Synthetic dyesNo checked product

    No checked Macitentan product lists synthetic dyes.

  5. GelatinNo checked product

    No checked Macitentan product lists gelatin.

Also listed by some products: Titanium dioxide 12 of 13 PEG or polysorbate 10 of 13 Sorbitol or mannitol 4 of 13

Find a version without it

Every current Macitentan product and what its label lists

Hide products that list:

ProductListsInactive ingredients on the label
Actelion Pharmaceuticals US, Inc. 1 product
10 mg tabletNDC 66215-0501-15 Still being read Not read yet
Alembic Pharmaceuticals Inc. 1 product
10 mg tabletNDC 62332-0373-30 Lactose Soy Titanium dioxide Polyethylene glycol or polysorbate
Show 11 ingredients

CROSCARMELLOSE SODIUM, LACTOSE MONOHYDRATE, LECITHIN, SOYBEAN, MICROCRYSTALLINE CELLULOSE, POLOXAMER 188, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED, SODIUM STEARYL FUMARATE, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Alembic Pharmaceuticals Limited 1 product
10 mg tabletNDC 46708-0373-30 Lactose Soy Titanium dioxide Polyethylene glycol or polysorbate
Show 11 ingredients

CROSCARMELLOSE SODIUM, LACTOSE MONOHYDRATE, LECITHIN, SOYBEAN, MICROCRYSTALLINE CELLULOSE, POLOXAMER 188, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED, SODIUM STEARYL FUMARATE, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Amneal Pharmaceuticals NY LLC 1 product
10 mg tabletNDC 69238-1327-03 Lactose Soy Titanium dioxide
Show 10 ingredients

LACTOSE MONOHYDRATE, LECITHIN, SOYBEAN, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, SODIUM STARCH GLYCOLATE TYPE A POTATO, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Apotex Corp. 1 product
10 mg tabletNDC 60505-4644-03 Titanium dioxide Polyethylene glycol or polysorbate
Show 7 ingredients

CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL 8000, POLYVINYL ALCOHOL, UNSPECIFIED, TALC, TITANIUM DIOXIDE
Aurobindo Pharma Limited 1 product
10 mg tabletNDC 59651-0147-30 Lactose Soy Titanium dioxide Polyethylene glycol or polysorbate
Show 10 ingredients

LACTOSE MONOHYDRATE, LECITHIN, SOYBEAN, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, SODIUM STARCH GLYCOLATE TYPE A POTATO, SODIUM STEARYL FUMARATE, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Laurus Labs Limited 1 product
10 mg tabletNDC 42385-0907-15 Soy Titanium dioxide Polyethylene glycol or polysorbate Sorbitol or mannitol
Show 11 ingredients

CROSPOVIDONE (120 .MU.M), MAGNESIUM STEARATE, MANNITOL, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, SOYBEAN LECITHIN, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Mylan Pharmaceuticals Inc. 1 product
10 mg tabletNDC 00378-0606-93 Lactose Titanium dioxide Polyethylene glycol or polysorbate
Show 11 ingredients

GLYCERYL MONO- AND DICAPRYLOCAPRATE, LACTOSE MONOHYDRATE, MICROCRYSTALLINE CELLULOSE 101, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, SODIUM LAURYL SULFATE, SODIUM STARCH GLYCOLATE TYPE A POTATO, SODIUM STEARYL FUMARATE, TALC, TITANIUM DIOXIDE
Novugen Pharma (USA) LLC 1 product
10 mg tabletNDC 82293-0041-10 Soy Titanium dioxide Polyethylene glycol or polysorbate Sorbitol or mannitol
Show 11 ingredients

MAGNESIUM STEARATE, MANNITOL, MICROCRYSTALLINE CELLULOSE, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED, SODIUM STARCH GLYCOLATE TYPE A POTATO, SOYBEAN LECITHIN, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Sandoz Inc 1 product
10 mg tabletNDC 00781-8135-31 Lactose Soy Titanium dioxide
Show 11 ingredients

LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, SODIUM LAURYL SULFATE, SODIUM STARCH GLYCOLATE TYPE A POTATO, SOYBEAN LECITHIN, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Sun Pharmaceutical Industries, Inc. 1 product
10 mg tabletNDC 47335-0070-15 Soy Titanium dioxide Polyethylene glycol or polysorbate Sorbitol or mannitol
Show 11 ingredients

CROSPOVIDONE (15 MPA.S AT 5%), LECITHIN, SOYBEAN, MAGNESIUM STEARATE, MANNITOL, MICROCRYSTALLINE CELLULOSE 101, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Teva Pharmaceuticals, Inc. 1 product
10 mg tabletNDC 00480-0915-56 None of these listed
Show 3 ingredients

MICROCRYSTALLINE CELLULOSE 101, MICROCRYSTALLINE CELLULOSE 102, POVIDONE K30
Torrent Pharmaceuticals Limited 1 product
10 mg tabletNDC 13668-0542-05 Soy Titanium dioxide Polyethylene glycol or polysorbate Sorbitol or mannitol
Show 12 ingredients

LECITHIN, SOYBEAN, MAGNESIUM STEARATE, MANNITOL, MICROCRYSTALLINE CELLULOSE 102, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE K30, SODIUM STARCH GLYCOLATE TYPE A POTATO, SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE, TALC, TITANIUM DIOXIDE, XANTHAN GUM
Zydus Pharmaceuticals USA Inc. 1 product
10 mg tabletNDC 70710-1166-03 Lactose Titanium dioxide Polyethylene glycol or polysorbate
Show 11 ingredients

CELLULOSE, MICROCRYSTALLINE, GLYCERYL MONOCAPRYLATE, LACTOSE MONOHYDRATE, POLYSORBATE 80, POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, SODIUM LAURYL SULFATE, SODIUM STARCH GLYCOLATE TYPE A POTATO, SODIUM STEARYL FUMARATE, TALC, TITANIUM DIOXIDE

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.

Macitentan without lactose

Lactose: milk sugar; a concern with lactose intolerance or a milk allergy. 7 of 13 checked products list lactose; 6 do not.

Does not list lactose

Lists lactose

Macitentan without soy

Soy: soybean oil or soy lecithin; a concern with soy allergy. 9 of 13 checked products list soy; 4 do not.

Does not list soy

Lists soy

Macitentan without titanium dioxide

Titanium dioxide: A white colorant some people choose to avoid. 12 of 13 checked products list titanium dioxide; 1 does not.

Does not list titanium dioxide

Lists titanium dioxide

Macitentan without polyethylene glycol or polysorbate

Polyethylene glycol or polysorbate: PEG, macrogol or polysorbate; a rare cause of allergic reactions. 10 of 13 checked products list polyethylene glycol or polysorbate; 3 do not.

Does not list polyethylene glycol or polysorbate

Lists polyethylene glycol or polysorbate

Macitentan without sorbitol or mannitol

Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. 4 of 13 checked products list sorbitol or mannitol; 9 do not.

Does not list sorbitol or mannitol

Lists sorbitol or mannitol

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 Macitentan product suits you →

Common questions about Macitentan inactive ingredients

Is Macitentan gluten-free?
This page cannot certify any Macitentan product gluten-free; it reports what each label declares. Of the 13 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 Macitentan contain lactose?
7 of 13 checked Macitentan products list lactose; 6 do not: Apotex (10 mg tablet), Laurus (10 mg tablet), Novugen (10 mg tablet) and Sun (10 mg tablet) 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 Macitentan contain soy?
9 of 13 checked Macitentan products list a soy ingredient (soybean oil or soy lecithin); 4 do not: Apotex (10 mg tablet), Mylan (10 mg tablet), Teva (10 mg tablet) and Zydus (10 mg tablet). 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 Macitentan?
No checked Macitentan 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 Macitentan contain gelatin?
No checked Macitentan 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 Macitentan 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 Macitentan 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 Macitentan guide