Inactive ingredients by manufacturer

Hydroxyurea inactive ingredients by manufacturer

Wondering whether your Hydroxyurea 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 Hydroxyurea 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 16 of the 21 current Hydroxyurea products on the market today, from 14 companies listing it with the FDA, and lined them up side by side. 4 are still being read and will appear on a later visit. 1 label has no inactive-ingredient list we could read, so that product cannot be compared.

Ask about your bottle

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

  1. LactoseDiffers by manufacturer

    10 of 16 checked products list lactose; 6 do not. See the products

    Does not list it American Health Packaging Coupler Major Medunik Par Health
    Lists it AvKARE Golden State Medical Supply H2-Pharma Leading Teva Waylis Therapeutics
  2. Wheat or gluten sourceNo checked product

    No checked Hydroxyurea product lists a wheat or gluten source.

  3. SoyNo checked product

    No checked Hydroxyurea product lists soy.

  4. Synthetic dyesDiffers by manufacturer

    14 of 16 checked products list synthetic dyes; 2 do not. See the products

    Does not list it Medunik
    Lists it American Health Packaging AvKARE Coupler Golden State Medical Supply H2-Pharma Leading Major Par Health Teva Waylis Therapeutics
  5. GelatinDiffers by manufacturer

    14 of 16 checked products list gelatin; 2 do not. See the products

    Does not list it Medunik
    Lists it American Health Packaging AvKARE Coupler Golden State Medical Supply H2-Pharma Leading Major Par Health Teva Waylis Therapeutics

Also listed by some products: Titanium dioxide 14 of 16 Carmine or shellac 5 of 16 Benzyl alcohol 1 of 16 Propylene glycol 4 of 16

Find a version without it

Every current Hydroxyurea product and what its label lists

Hide products that list:

ProductListsInactive ingredients on the label
American Health Packaging 1 product
500 mg capsuleNDC 68084-0284-01 Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 12 ingredients

AMMONIA, D&C YELLOW NO. 10, FD&C BLUE NO. 1, FD&C BLUE NO. 2, FD&C RED NO. 40, FERROSOFERRIC OXIDE, GELATIN, UNSPECIFIED, MAGNESIUM STEARATE, PROPYLENE GLYCOL, SHELLAC, SILICON DIOXIDE, TITANIUM DIOXIDE
AvKARE 1 product
500 mg capsuleNDC 42291-0321-01 Lactose Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Benzyl alcohol Propylene glycol
Show 23 ingredients

ANHYDROUS CITRIC ACID, BENZYL ALCOHOL, BUTYLPARABEN, CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM, D&C RED NO. 28, D&C YELLOW NO. 10, EDETATE CALCIUM DISODIUM, FD&C BLUE NO. 1, FD&C BLUE NO. 2, FD&C RED NO. 40, FERRIC OXIDE RED, FERROSOFERRIC OXIDE, GELATIN, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, METHYLPARABEN, PROPYLENE GLYCOL, PROPYLPARABEN SODIUM, SHELLAC, SODIUM LAURYL SULFATE, SODIUM PHOSPHATE, DIBASIC, SODIUM PROPIONATE, TITANIUM DIOXIDE
Coupler LLC 1 product
500 mg capsuleNDC 67046-1619-03 Synthetic dyes Titanium dioxide Gelatin Carmine or shellac
Show 9 ingredients

FD&C BLUE NO. 1, FD&C RED NO. 3, FERROSOFERRIC OXIDE, GELATIN, MAGNESIUM STEARATE, POTASSIUM HYDROXIDE, SHELLAC, SILICON DIOXIDE, TITANIUM DIOXIDE
Golden State Medical Supply, Inc. 1 product
500 mg capsuleNDC 51407-0909-01 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 8 ingredients

ANHYDROUS LACTOSE, D&C YELLOW NO. 10, FD&C BLUE NO. 1, FD&C RED NO. 3, GELATIN, MAGNESIUM STEARATE, SILICON DIOXIDE, TITANIUM DIOXIDE
H2-Pharma LLC 4 products
200 mg capsuleNDC 61269-0402-60 Still being read Not read yet
300 mg capsuleNDC 61269-0403-60 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 9 ingredients

citric acid monohydrate, D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, magnesium stearate, sodium phosphate, titanium dioxide
400 mg capsuleNDC 61269-0404-60 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 9 ingredients

citric acid monohydrate, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, magnesium stearate, sodium phosphate, titanium dioxide
500 mg capsuleNDC 61269-0835-10 Still being read Not read yet
Leading Pharma, LLC 1 product
500 mg capsuleNDC 69315-0164-01 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 8 ingredients

ANHYDROUS LACTOSE, D&C YELLOW NO. 10, FD&C BLUE NO. 1, FD&C RED NO. 3, GELATIN, MAGNESIUM STEARATE, SILICON DIOXIDE, TITANIUM DIOXIDE
Major Pharmaceuticals 1 product
500 mg capsuleNDC 00904-6939-61 Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 15 ingredients

AMMONIA, D&C YELLOW NO. 10, D&C YELLOW NO. 10 ALUMINUM LAKE, FD&C BLUE NO. 1, FD&C BLUE NO. 1 ALUMINUM LAKE, FD&C BLUE NO. 2 ALUMINUM LAKE, FD&C RED NO. 40, FD&C RED NO. 40 ALUMINUM LAKE, FERROSOFERRIC OXIDE, GELATIN, UNSPECIFIED, MAGNESIUM STEARATE, PROPYLENE GLYCOL, SHELLAC, SILICON DIOXIDE, TITANIUM DIOXIDE
Medunik 2 products
100 mg tabletNDC 71770-0105-60 None of these listed
Show 5 ingredients

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER, ISOPROPYL ALCOHOL, MICROCRYSTALLINE CELLULOSE, SILICON DIOXIDE, SODIUM STEARYL FUMARATE
1000 mg tabletNDC 71770-0120-30 None of these listed
Show 5 ingredients

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER, ISOPROPYL ALCOHOL, MICROCRYSTALLINE CELLULOSE, SILICON DIOXIDE, SODIUM STEARYL FUMARATE
Nova Laboratories, Ltd. 1 product
100 mg/mL oral solutionNDC 62484-0015-05 No inactive-ingredient list on the label No list we could read
Par Health USA, LLC 1 product
500 mg capsuleNDC 49884-0724-01 Synthetic dyes Titanium dioxide Gelatin
Show 7 ingredients

D&C YELLOW NO. 10, FD&C BLUE NO. 1, FD&C RED NO. 40, GELATIN, MAGNESIUM STEARATE, SILICON DIOXIDE, TITANIUM DIOXIDE
Qilu Pharmaceutical Co., Ltd. 1 product
500 mg capsuleNDC 67184-0607-01 Still being read Not read yet
Somerset Therapeutics, LLC 1 product
500 mg capsuleNDC 70069-0820-01 Still being read Not read yet
Teva Pharmaceuticals USA, Inc. 1 product
500 mg capsuleNDC 00555-0882-02 Lactose Synthetic dyes Titanium dioxide Gelatin Carmine or shellac Propylene glycol
Show 17 ingredients

ANHYDROUS CITRIC ACID, D&C RED NO. 28, D&C YELLOW NO. 10 ALUMINUM LAKE, FD&C BLUE NO. 1, FD&C BLUE NO. 1 ALUMINUM LAKE, FD&C BLUE NO. 2--ALUMINUM LAKE, FD&C RED NO. 40, FERRIC OXIDE RED, FERROSOFERRIC OXIDE, GELATIN, LACTOSE MONOHYDRATE, MAGNESIUM STEARATE, PROPYLENE GLYCOL, SHELLAC, SODIUM LAURYL SULFATE, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS, TITANIUM DIOXIDE
Waylis Therapeutics LLC 4 products
200 mg capsuleNDC 80725-0820-60 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 8 ingredients

CITRIC ACID MONOHYDRATE, FD&C BLUE NO. 1, FD&C GREEN NO. 3, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, MAGNESIUM STEARATE, SODIUM PHOSPHATE, TITANIUM DIOXIDE
300 mg capsuleNDC 80725-0830-60 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 9 ingredients

CITRIC ACID MONOHYDRATE, D&C RED NO. 28, D&C RED NO. 33, FD&C BLUE NO. 1, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, MAGNESIUM STEARATE, SODIUM PHOSPHATE, TITANIUM DIOXIDE
400 mg capsuleNDC 80725-0840-60 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 9 ingredients

CITRIC ACID MONOHYDRATE, D&C RED NO. 28, D&C RED NO. 33, D&C YELLOW NO. 10, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, MAGNESIUM STEARATE, SODIUM PHOSPHATE, TITANIUM DIOXIDE
500 mg capsuleNDC 80725-0810-10 Lactose Synthetic dyes Titanium dioxide Gelatin
Show 10 ingredients

CITRIC ACID MONOHYDRATE, D&C RED NO. 28, D&C YELLOW NO. 10, FD&C BLUE NO. 1, FD&C RED NO. 40, GELATIN, UNSPECIFIED, LACTOSE, UNSPECIFIED FORM, MAGNESIUM STEARATE, SODIUM PHOSPHATE, 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.

Hydroxyurea without lactose

Lactose: milk sugar; a concern with lactose intolerance or a milk allergy. 10 of 16 checked products list lactose; 6 do not.

Does not list lactose

Lists lactose

Hydroxyurea without synthetic dyes

Synthetic dyes: FD&C or D&C colorants and their aluminum lakes. 14 of 16 checked products list synthetic dyes; 2 do not.

Does not list synthetic dyes

Lists synthetic dyes

Hydroxyurea without gelatin

Gelatin: animal-derived (usually bovine or porcine); a concern for vegetarian, kosher or halal needs. 14 of 16 checked products list gelatin; 2 do not.

Does not list gelatin

Lists gelatin

Hydroxyurea without titanium dioxide

Titanium dioxide: A white colorant some people choose to avoid. 14 of 16 checked products list titanium dioxide; 2 do not.

Does not list titanium dioxide

Lists titanium dioxide

Hydroxyurea without carmine or shellac

Carmine or shellac: insect-derived red colorant or coating glaze. 5 of 16 checked products list carmine or shellac; 11 do not.

Does not list carmine or shellac

Lists carmine or shellac

Hydroxyurea without benzyl alcohol

Benzyl alcohol: A preservative, mostly in injections and liquids; not for newborns. 1 of 16 checked products list benzyl alcohol; 15 do not.

Does not list benzyl alcohol

Lists benzyl alcohol

Hydroxyurea without propylene glycol

Propylene glycol: A solvent in liquids and capsules; a concern in kidney disease, for infants, and at high doses. 4 of 16 checked products list propylene glycol; 12 do not.

Does not list propylene glycol

Lists propylene glycol

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 Hydroxyurea product suits you →

Common questions about Hydroxyurea inactive ingredients

Is Hydroxyurea gluten-free?
This page cannot certify any Hydroxyurea product gluten-free; it reports what each label declares. Of the 16 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 Hydroxyurea contain lactose?
10 of 16 checked Hydroxyurea products list lactose; 6 do not: American Health Packaging (500 mg capsule), Coupler (500 mg capsule), Major (500 mg capsule) and Medunik (100 mg tablet and 1000 mg tablet) and 1 other company. 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 Hydroxyurea contain soy?
No checked Hydroxyurea 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 Hydroxyurea?
14 of 16 checked Hydroxyurea products list a synthetic dye (an FD&C or D&C colorant); 2 do not: Medunik (100 mg tablet and 1000 mg tablet). Colorants often differ by strength within one company's line, so compare the lists above strength by strength.
Does Hydroxyurea contain gelatin?
14 of 16 checked Hydroxyurea products list gelatin; 2 do not: Medunik (100 mg tablet and 1000 mg tablet). 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 Hydroxyurea 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 5, 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 Hydroxyurea 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 Hydroxyurea guide