Prescription medicine
Sulfadiazine
Sulfadiazine is a prescription medicine with an FDA approval on record since 1941. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $15.06 per sulfadiazine 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sulfadiazine FDA label on DailyMed (effective September 24, 2024, Chartwell RX, LLC); the NDA 4054 record on Drugs@FDA; every sulfadiazine label on DailyMed.
Highlights of the record
FDA label of September 24, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSulfadiazine Tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus,
Forms and strengths
- 500 mg
Tablet.
On the market
- Earliest approval on file
- August 11, 1941 Sulfadiazine, Lederle; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first July 5, 1978; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $15.06 per tablet Sulfadiazine 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,677 through July 30, 2026
What is sulfadiazine used for?
From the label: indications and usageSulfadiazine Tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris. Sulfadiazine should be used for urinary tract infections only after use of more soluble sulfonamides has been unsuccessful. […]
Conditions named in the indications of sulfadiazine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sulfonamide Antibacterial.
Source: FDA drug label (sulfADIAZINE), Chartwell RX, LLC, effective September 24, 2024 (SPL set 6032d6f7-cbce-4e5d-841c-a1e24b616f91), via openFDA; the full label on DailyMed
Is there a generic for sulfadiazine?
The FDA approved the first generic sulfadiazine on July 5, 1978. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sulfadiazine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1941 earliest approval on file
- 1978 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sulfadiazine?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $15.06 per Sulfadiazine 500 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sulfadiazine 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sulfadiazine 500 mg tablet | Generic | $15.06 per tablet | $451.94 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the sulfadiazine label say about other medicines?
The sulfadiazine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name sulfadiazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Pyrimethamine | contraindications | In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis). |
Source: FDA drug label (sulfADIAZINE), Chartwell RX, LLC, effective September 24, 2024 (SPL set 6032d6f7-cbce-4e5d-841c-a1e24b616f91), via openFDA; the full label on DailyMed
What do FAERS reports show for sulfadiazine?
The FDA Adverse Event Reporting System holds 1,677 reports that list sulfadiazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 264 are coded as a death and 701 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sulfadiazine?
9 other medicines are given the same way (oral) and in the same FDA class as sulfadiazine or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Doxycycline | Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin and clavulanate | Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Nitrofurantoin | Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
| Minocycline | Urinary tract infections | 21 labelers | $0.343 per capsule 100 mg capsule | No current entry |
| Methenamine | Urinary tract infections | 10 labelers | $0.313 per tablet 1 g tablet | No current entry |
| Fosfomycin | Urinary tract infections | 10 labelers | $26.22 per unit 3 g sachet | No current entry |
| Gepotidacin | Urinary tract infections | none listed | $91.40 per tablet 750 mg tablet | No current entry |
| Pivmecillinam | Urinary tract infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as sulfadiazine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sulfadiazine
- 9 medicines for the same use
- Other sulfonamide antibacterials
- the pharmacologic class, with prices and generics
- Sulfadiazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other