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Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and Trimethoprim · SULFAMETHOXAZOLE 80 mg/mL; TRIMETHOPRIM 16 mg/mL · Injection, Solution, Concentrate · Intravenous · Somerset Therapeutics, LLC

NDC 70069-0363-01 · 1 VIAL in 1 CARTON / 30 mL in 1 VIAL · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$36.49
Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicare Part B (ASP)

Payment limit per 5MG-1MG
$0.036
HCPCS J2865 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2025)

$2,685
39 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA212231
TE code
AP
Approval date
Jun 26, 2019
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Sulfamethoxazole and Trimethoprim (Injection, Solution, Concentrate)

LabelerStrengthFirst seenLast seen
Somerset Therapeutics, LLCSULFAMETHOXAZOLE 80 mg/mL; TRIMETHOPRIM 16 mg/mLJul 15, 2026Sep 3, 2026
Teva Parenteral Medicines, Inc.SULFAMETHOXAZOLE 80 mg/mL; TRIMETHOPRIM 16 mg/mLJul 15, 2026Sep 3, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Sulfamethoxazole and Trimethoprim — NDC 70069-0363-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069036301.

Free to cite with attribution — see how the data is put together.