Nitisinone Inactive Ingredients by Manufacturer

Wondering whether your Nitisinone has lactose, gluten, soy, a dye or gelatin in it?

  • Lactose
  • Gluten source
  • Soy
  • Dyes
  • Gelatin

Same medicine, different fillers. The coatings, colors and fillers differ from one company to the next. This page shows what each Nitisinone product's FDA label lists, so you can pick a version that leaves out what you avoid.

  1. 1Find your product
  2. 2See what its label lists
  3. 3Ask for it by its NDC
23FDA labels read
6companies compared
Dr. Brian Staiger, PharmD, BCPS
Curated and coded by , clinical pharmacist Updated October 6, 2026 · how this page is built
Don’t see your specific product? Ask us

Answers from the FDA labels

Ask About the Inactive Ingredients in Your Nitisinone

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.

Check your bottle

Look Up Your Nitisinone by NDC, Company or Strength

Pick your bottle and tap what you want to check. The answer comes from that product's own FDA label, which is already on this page.

1 Which bottle do you have?

Or tap your way to it: the form, then the strength, then the company.

Form

2 What do you want to check?

Nothing tapped? We check the five big ones.

  • Listed on the labelthe company names it.
  • Not listedthe label does not name it.
  • Source unclearthe label names a starch or maltodextrin without saying what plant it came from.
  • Still being readwe have not finished this label yet.
Nitisinone Your bottle Pick a product and this label fills in.

Pick your bottle to read its label, or tap an ingredient to see which Nitisinone products leave it out.

Summary of all Nitisinone products

The checker above looks at one bottle. This is every current Nitisinone product at once: 23 FDA labels from 6 companies.

Which Nitisinone Products List Lactose, a Gluten Source, Soy, Dyes or Gelatin?

  1. LactoseDiffers by manufacturer

    8 of 23 checked products list lactose; 15 do not. See which products do not list it

  2. Wheat or gluten sourceNo checked product

    No checked Nitisinone product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Nitisinone product lists soy.

  4. Synthetic dyesDiffers by manufacturer

    4 of 23 checked products list synthetic dyes; 19 do not. See which products do not list it

  5. GelatinDiffers by manufacturer

    14 of 23 checked products list gelatin; 9 do not. See which products do not list it

Also listed by some products: Corn 8 of 23 Titanium dioxide 14 of 23 Carmine or shellac 4 of 23 Propylene glycol 10 of 23 PEG or polysorbate 1 of 23 Sorbitol or mannitol 6 of 23

Details of all Nitisinone products

Every current Nitisinone product, grouped by strength and form. Open one to see each company's NDC, package sizes and full inactive-ingredient list.

Find a version without it

Every Current Nitisinone Product and What Its Label Lists

Fastest way: search by NDC. It is printed on your bottle's pharmacy label. If it is not, call your pharmacy: they have it on record.

Hide products that list:

Nitisinone 2 mg capsule 5 companies Corn-derived 2 Synthetic dyes 1 Titanium dioxide 4 Gelatin 4 Carmine or shellac 1 Propylene glycol 3 Sorbitol or mannitol 2 Lactose 1
CompanyListsInactive ingredients on the label
AnalogNDC 70505-0202-60 Corn-derived Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 8 ingredients

AMMONIA, FD&C BLUE NO. 2--ALUMINUM LAKE, GELATIN, UNSPECIFIED, MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE), PROPYLENE GLYCOL, SHELLAC, STEARIC ACID, TITANIUM DIOXIDE

Bryant Ranch PrepackNDC 63629-2234-01 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, UNSPECIFIED, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EndoNDC 00254-3020-02 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EtonNDC 71863-0119-60 Lactose
Show 2 ingredients

ANHYDROUS LACTOSE, STEARIC ACID

Swedish Orphan Biovitrum AbNDC 66658-0102-60 Corn-derived Titanium dioxide Gelatin
Show 3 ingredients

GELATIN, STARCH, CORN, TITANIUM DIOXIDE
Nitisinone 5 mg capsule 5 companies Corn-derived 2 Synthetic dyes 1 Titanium dioxide 4 Gelatin 4 Carmine or shellac 1 Propylene glycol 3 Sorbitol or mannitol 2 Lactose 1
CompanyListsInactive ingredients on the label
AnalogNDC 70505-0205-60 Corn-derived Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 8 ingredients

AMMONIA, FD&C BLUE NO. 2--ALUMINUM LAKE, GELATIN, UNSPECIFIED, MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE), PROPYLENE GLYCOL, SHELLAC, STEARIC ACID, TITANIUM DIOXIDE

Bryant Ranch PrepackNDC 63629-2235-01 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, UNSPECIFIED, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EndoNDC 00254-3021-02 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EtonNDC 71863-0120-60 Lactose
Show 2 ingredients

ANHYDROUS LACTOSE, STEARIC ACID

Swedish Orphan Biovitrum AbNDC 66658-0105-60 Corn-derived Titanium dioxide Gelatin
Show 3 ingredients

GELATIN, STARCH, CORN, TITANIUM DIOXIDE
Nitisinone 10 mg capsule 5 companies Corn-derived 2 Synthetic dyes 1 Titanium dioxide 4 Gelatin 4 Carmine or shellac 1 Propylene glycol 3 Sorbitol or mannitol 2 Lactose 1
CompanyListsInactive ingredients on the label
AnalogNDC 70505-0210-60 Corn-derived Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 8 ingredients

AMMONIA, FD&C BLUE NO. 2--ALUMINUM LAKE, GELATIN, UNSPECIFIED, MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE), PROPYLENE GLYCOL, SHELLAC, STEARIC ACID, TITANIUM DIOXIDE

Bryant Ranch PrepackNDC 63629-2233-01 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, UNSPECIFIED, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EndoNDC 00254-3022-02 Titanium dioxide Gelatin Propylene glycol Sorbitol or mannitol
Show 11 ingredients

AMMONIA, ANHYDROUS CITRIC ACID, FERROSOFERRIC OXIDE, GELATIN, HYPROMELLOSE 2910 (5 MPA.S), MANNITOL, POTASSIUM HYDROXIDE, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, STEARIC ACID, TITANIUM DIOXIDE

EtonNDC 71863-0121-60 Lactose
Show 2 ingredients

ANHYDROUS LACTOSE, STEARIC ACID

Swedish Orphan Biovitrum AbNDC 66658-0110-60 Corn-derived Titanium dioxide Gelatin
Show 3 ingredients

GELATIN, STARCH, CORN, TITANIUM DIOXIDE
Nitisinone 20 mg capsule 3 companies Corn-derived 2 Synthetic dyes 1 Titanium dioxide 2 Gelatin 2 Carmine or shellac 1 Propylene glycol 1 Lactose 1
CompanyListsInactive ingredients on the label
AnalogNDC 70505-0220-60 Corn-derived Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 8 ingredients

AMMONIA, FD&C BLUE NO. 2--ALUMINUM LAKE, GELATIN, UNSPECIFIED, MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE), PROPYLENE GLYCOL, SHELLAC, STEARIC ACID, TITANIUM DIOXIDE

EtonNDC 71863-0122-60 Lactose
Show 2 ingredients

ANHYDROUS LACTOSE, STEARIC ACID

Swedish Orphan Biovitrum AbNDC 66658-0120-60 Corn-derived Titanium dioxide Gelatin
Show 3 ingredients

GELATIN, STARCH, CORN, TITANIUM DIOXIDE
Nitisinone 2 mg tablet 1 company, 2 products Lactose 2
CompanyListsInactive ingredients on the label
CycleNDC 70709-0002-60 Lactose
Show 2 ingredients

GLYCERYL DIBEHENATE, LACTOSE MONOHYDRATE

CycleNDC 70709-0112-60 Lactose
Show 2 ingredients

GLYCERYL DIBEHENATE, LACTOSE MONOHYDRATE
Nitisinone 5 mg tablet 1 company Lactose 1
CompanyListsInactive ingredients on the label
CycleNDC 70709-0005-60 Lactose
Show 2 ingredients

GLYCERYL DIBEHENATE, LACTOSE MONOHYDRATE
Nitisinone 10 mg tablet 1 company Lactose 1
CompanyListsInactive ingredients on the label
CycleNDC 70709-0000-60 Lactose
Show 2 ingredients

GLYCERYL DIBEHENATE, LACTOSE MONOHYDRATE
Nitisinone 4 mg/mL oral suspension 1 company Polyethylene glycol or polysorbate 1
CompanyListsInactive ingredients on the label
Swedish Orphan Biovitrum AbNDC 66658-0204-90 Polyethylene glycol or polysorbate
Show 7 ingredients

CITRIC ACID MONOHYDRATE, GLYCERIN, HYPROMELLOSES, POLYSORBATE 80, SODIUM BENZOATE, TRISODIUM CITRATE DIHYDRATE, WATER

A product with none of these on its label may still contain them. The label shows only what the company listed, and it often does not say where a starch or a flavor comes from. Some companies here repackage or sell another company's product under their own name. Tap an NDC to open that product's page with its full label.

Nitisinone Without Lactose

Lactose: milk sugar; a concern with lactose intolerance or a milk allergy. 8 of 23 checked products list lactose; 15 do not.

Show which Nitisinone products list lactose and which do not, by product and company

Does Not List Lactose

Lists Lactose

Nitisinone Without Synthetic Dyes

Synthetic dyes: FD&C or D&C colorants and their aluminum lakes. 4 of 23 checked products list synthetic dyes; 19 do not.

Show which Nitisinone products list synthetic dyes and which do not, by product and company

Does Not List Synthetic Dyes

Lists Synthetic Dyes

Nitisinone Without Gelatin

Gelatin: animal-derived (usually bovine or porcine); a concern for vegetarian, kosher or halal needs. 14 of 23 checked products list gelatin; 9 do not.

Show which Nitisinone products list gelatin and which do not, by product and company

Does Not List Gelatin

Lists Gelatin

  • 2 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 5 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 10 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 20 mg capsule: Analog, Swedish Orphan Biovitrum Ab

Nitisinone Without Corn-Derived Ingredients

Corn-derived: corn starch, maize or corn syrup; a concern with corn allergy. 8 of 23 checked products list corn-derived ingredients; 15 do not.

Show which Nitisinone products list corn-derived ingredients and which do not, by product and company

Does Not List Corn-Derived Ingredients

Lists Corn-Derived Ingredients

Nitisinone Without Titanium Dioxide

Titanium dioxide: A white colorant some people choose to avoid. 14 of 23 checked products list titanium dioxide; 9 do not.

Show which Nitisinone products list titanium dioxide and which do not, by product and company

Does Not List Titanium Dioxide

Lists Titanium Dioxide

  • 2 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 5 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 10 mg capsule: Analog, Bryant Ranch Prepack, Endo, Swedish Orphan Biovitrum Ab
  • 20 mg capsule: Analog, Swedish Orphan Biovitrum Ab

Nitisinone Without Carmine or Shellac

Carmine or shellac: insect-derived red colorant or coating glaze. 4 of 23 checked products list carmine or shellac; 19 do not.

Show which Nitisinone products list carmine or shellac and which do not, by product and company

Does Not List Carmine or Shellac

Lists Carmine or Shellac

Nitisinone Without Propylene Glycol

Propylene glycol: A solvent in liquids and capsules; a concern in kidney disease, for infants, and at high doses. 10 of 23 checked products list propylene glycol; 13 do not.

Show which Nitisinone products list propylene glycol and which do not, by product and company

Does Not List Propylene Glycol

Lists Propylene Glycol

Nitisinone Without Polyethylene Glycol or Polysorbate

Polyethylene glycol or polysorbate: PEG, macrogol or polysorbate; a rare cause of allergic reactions. 1 of 23 checked products list polyethylene glycol or polysorbate; 22 do not.

Show which Nitisinone products list polyethylene glycol or polysorbate and which do not, by product and company

Does Not List Polyethylene Glycol or Polysorbate

Lists Polyethylene Glycol or Polysorbate

Nitisinone Without Sorbitol or Mannitol

Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. 6 of 23 checked products list sorbitol or mannitol; 17 do not.

Show which Nitisinone products list sorbitol or mannitol and which do not, by product and company

Does Not List Sorbitol or Mannitol

Lists Sorbitol or Mannitol

At the pharmacy counter

How to Get the Version You Want at the Pharmacy

  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 Nitisinone product suits you →

Common Questions About Nitisinone Inactive Ingredients

Is Nitisinone gluten-free?
This page cannot promise any Nitisinone product has no gluten; it reports what each label declares. Of the 23 products checked, none lists a wheat, barley, rye or gluten ingredient, and none lists a starch or maltodextrin 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 Nitisinone contain lactose?
8 of 23 checked Nitisinone products list lactose; 15 do not: Analog (2 mg capsule, 5 mg capsule and 10 mg capsule and 1 more), Bryant Ranch Prepack (2 mg capsule, 5 mg capsule and 10 mg capsule), Endo (2 mg capsule, 5 mg capsule and 10 mg capsule) and Swedish Orphan Biovitrum Ab (2 mg capsule, 5 mg capsule and 10 mg capsule and 2 more). 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 Nitisinone contain soy?
No checked Nitisinone 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 Nitisinone?
4 of 23 checked Nitisinone products list a synthetic dye (an FD&C or D&C colorant); 19 do not: Bryant Ranch Prepack (2 mg capsule, 5 mg capsule and 10 mg capsule), Cycle (2 mg tablet, 5 mg tablet and 10 mg tablet), Endo (2 mg capsule, 5 mg capsule and 10 mg capsule) and Eton (2 mg capsule, 5 mg capsule and 10 mg capsule and 1 more) and 1 other company. Colorants often differ by strength within one company's line, so compare the lists above strength by strength.
Does Nitisinone contain gelatin?
14 of 23 checked Nitisinone products list gelatin; 9 do not: Cycle (2 mg tablet, 5 mg tablet and 10 mg tablet), Eton (2 mg capsule, 5 mg capsule and 10 mg capsule and 1 more) and Swedish Orphan Biovitrum Ab (4 mg/mL oral suspension). 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 Nitisinone product can list lactose and a dye while another from a different company lists neither.
What can a label not tell me?
A label tells you every inactive ingredient the company names for that product. It cannot tell you where an unnamed flavor, starch or maltodextrin came from, whether traces come from shared equipment, or about a change made after our last read of the label (October 6, 2026). Your pharmacist can check with the manufacturer.
Who decides what counts as a gluten source, a dye or soy on this page?
Dr. Brian Staiger, PharmD, BCPS, a clinical pharmacist, wrote and maintains the classification this page applies: which ingredient names count as a lactose, wheat or gluten, soy, synthetic dye or gelatin source, and which read as "source not stated" (bare starch or maltodextrin). The ingredient lists themselves are the manufacturers' own FDA labels, shown as filed; nothing is added to or removed from a label.
The NDC on my bottle ends differently from the one on this page. Is it the same product?
Usually, yes. An NDC has three parts: the company, the product (the medicine, strength and form) and, last, the package size. Two codes that share the first two parts are the same product in different pack sizes, and a label belongs to the product, so every pack size shares one inactive-ingredient list. Each product on this page lists every pack size the FDA directory holds for it, and the NDC search accepts any of them.
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?
We have read the FDA labels of 23 of the 23 current Nitisinone products on the market today, from 6 companies listing it with the FDA, and lined them up side by side. The products are the ones in the FDA's current NDC directory as of October 6, 2026. The list is rebuilt every day, the FDA directory is re-imported every week, and each inactive-ingredient list is the manufacturer's FDA label as our label sync last read it, re-read when the FDA publishes a new version. 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 Nitisinone 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 Nitisinone guide