Sapropterin Inactive Ingredients by Manufacturer

Wondering whether your Sapropterin 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 Sapropterin 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
18FDA labels read
8companies 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 Sapropterin

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 Sapropterin 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.
Sapropterin Your bottle Pick a product and this label fills in.

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

Summary of all Sapropterin products

The checker above looks at one bottle. This is every current Sapropterin product at once: 18 FDA labels from 8 companies.

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

  1. LactoseNo checked product

    No checked Sapropterin product lists lactose.

  2. Wheat or gluten sourceNo checked product

    No checked Sapropterin product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Sapropterin product lists soy.

  4. Synthetic dyesNo checked product

    No checked Sapropterin product lists synthetic dyes.

  5. GelatinNo checked product

    No checked Sapropterin product lists gelatin.

Also listed by some products: Sorbitol or mannitol 18 of 18

Details of all Sapropterin products

Every current Sapropterin 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 Sapropterin 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:

Sapropterin 100 mg oral solution 8 companies Sorbitol or mannitol 6
CompanyListsInactive ingredients on the label
AuctaNDC 73289-0070-02 No inactive-ingredient list on the label No list we could read
BioMarinNDC 68135-0301-22 No inactive-ingredient list on the label No list we could read
CamberNDC 31722-0047-30 Same product, other package sizes: 31722-0047-31 (carton / 1 powder of 1 packet) Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Dr. ReddysNDC 43598-0097-30 White liquid Sorbitol or mannitol
Show 4 ingredients

Ascorbic Acid, Mannitol, Potassium Citrate, Sucralose
MicroNDC 42571-0509-41 Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
NorthStar RxLLCNDC 72603-0193-30 Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Par HealthNDC 49884-0948-72 Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
TrupharmaNDC 52817-0850-01 Same product, other package sizes: 52817-0850-30 (carton of 30 powders) Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Sapropterin 500 mg oral solution 8 companies Sorbitol or mannitol 6
CompanyListsInactive ingredients on the label
AuctaNDC 73289-0071-02 No inactive-ingredient list on the label No list we could read
BioMarinNDC 68135-0482-11 No inactive-ingredient list on the label No list we could read
CamberNDC 31722-0048-30 Same product, other package sizes: 31722-0048-31 (carton / 1 powder of 1 packet) Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Dr. ReddysNDC 43598-0162-30 Sorbitol or mannitol
Show 4 ingredients

Ascorbic Acid, Mannitol, Potassium Citrate, Sucralose
MicroNDC 42571-0510-41 Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
NorthStar RxLLCNDC 72603-0194-30 Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Par HealthNDC 49884-0873-72 White liquid Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
TrupharmaNDC 52817-0851-01 Same product, other package sizes: 52817-0851-30 (carton of 30 powders) Sorbitol or mannitol
Show 4 ingredients

ASCORBIC ACID, MANNITOL, POTASSIUM CITRATE, SUCRALOSE
Sapropterin 100 mg tablet 7 companies, 8 products Sorbitol or mannitol 6
CompanyListsInactive ingredients on the label
AurobindoNDC 59651-0574-08 White round tablet, 10 mm, imprint S1 Same product, other package sizes: 59651-0574-24 (bottle of 240 tablets), 59651-0574-30 (bottle of 30 tablets) Sorbitol or mannitol
Show 6 ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE, ASCORBIC ACID, CROSPOVIDONE (120 .MU.M), MANNITOL, RIBOFLAVIN, SODIUM STEARYL FUMARATE
BioMarinNDC 68135-0300-02 No inactive-ingredient list on the label No list we could read
CamberNDC 31722-0045-12 White round tablet, 10 mm, imprint I1 Sorbitol or mannitol
Show 6 ingredients

ASCORBIC ACID, CROSPOVIDONE (120 .MU.M), MANNITOL, RIBOFLAVIN, SILICON DIOXIDE, SODIUM STEARYL FUMARATE
Dr. ReddysNDC 43598-0096-04 White round tablet, 9 mm, imprint l Same product, other package sizes: 43598-0096-05 (bottle of 500 tablets), 43598-0096-30 (bottle of 30 tablets) Sorbitol or mannitol
Show 7 ingredients

ASCORBIC ACID, CROSPOVIDONE, HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED, MANNITOL, RIBOFLAVIN, SILICON DIOXIDE, SODIUM STEARYL FUMARATE
Dr. ReddysNDC 43598-0749-04 Same product, other package sizes: 43598-0749-13 (case / 120 tablet in 1 bottle of 8,000 bottles) No current label Not available
HikmaNDC 00054-0906-23 Sorbitol or mannitol
Show 6 ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE, ASCORBIC ACID, CROSPOVIDONE (120 .MU.M), MANNITOL, RIBOFLAVIN, SODIUM STEARYL FUMARATE
NorthStar RxLLCNDC 72603-0191-01 Sorbitol or mannitol
Show 6 ingredients

ASCORBIC ACID, CROSPOVIDONE (120 .MU.M), MANNITOL, RIBOFLAVIN, SILICON DIOXIDE, SODIUM STEARYL FUMARATE
Par HealthNDC 49884-0720-08 Sorbitol or mannitol
Show 8 ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE, ASCORBIC ACID, COPOVIDONE K25-31, CROSPOVIDONE, MANNITOL, RIBOFLAVIN, SILICON DIOXIDE, SODIUM STEARYL FUMARATE

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.

Sapropterin and Sorbitol or Mannitol

Sorbitol or mannitol: sugar alcohols that can cause bloating or diarrhea in larger amounts. Every checked Sapropterin product (18) lists sorbitol or mannitol.

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

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 Sapropterin product suits you →

Common Questions About Sapropterin Inactive Ingredients

Is Sapropterin gluten-free?
This page cannot promise any Sapropterin product has no gluten; it reports what each label declares. Of the 18 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 Sapropterin contain lactose?
No checked Sapropterin 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 Sapropterin contain soy?
No checked Sapropterin 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 Sapropterin?
No checked Sapropterin 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 Sapropterin contain gelatin?
No checked Sapropterin 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 Sapropterin 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 18 of the 24 current Sapropterin products on the market today, from 10 companies listing it with the FDA, and lined them up side by side. 5 labels have no inactive-ingredient list we could read, so those products cannot be compared. 1 could not be linked to a current label. 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 Sapropterin 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 Sapropterin guide