Cromolyn Sodium Concentrate (Gastrocrom) Shortage: Current FDA Status and Availability

Drug Shortages medium FDA · · United States

The FDA reports an ongoing shortage of Cromolyn Sodium Concentrate, used for pulmonary and allergy conditions, though major manufacturers currently report availability.

What’s in Shortage

Cromolyn Sodium Concentrate (generic) and its brand-name version, Gastrocrom, are currently listed on the FDA drug shortage database. This medication is categorized under Pulmonary/Allergy therapeutics and is supplied in a concentrate dosage form.

  • Current Status: Current
  • Initial Posting Date: 11/03/2023
  • Last Updated: 02/04/2026

Which Manufacturers Are Affected

According to the latest FDA data, the following manufacturers are involved in the supply of this medication. While the shortage remains on the active list, both manufacturers currently report their specific presentations as available:

  • Mylan Specialty, a Viatris Company

    • Status: Available
    • Presentation: Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96)
    • Contact Info: (800) 796-9526
  • Micro Labs LTD

    • Status: Available
    • Presentation: Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52)
    • Contact Info: (908) 484-7410

Why There’s a Shortage

At this time, the FDA has not provided a specific reason for the shortage of Cromolyn Sodium Concentrate.

What Patients Should Do

If you or a family member depends on this medication, the following steps are recommended to ensure continuity of care:

  • Consult your pharmacist: Local supply may vary. Your pharmacist can check regional stock and provide updates on when new shipments are expected.
  • Talk to your healthcare provider: Discuss your treatment options and ask about alternatives if you have difficulty obtaining your regular prescription.
  • Contact the manufacturer: For specific questions regarding supply and distribution, you may reach out to the manufacturers directly using the phone numbers provided above.

Disclaimer: This article is for informational purposes only. Patients should always consult with their healthcare provider or a qualified medical professional regarding their treatment and any potential changes to their medication regimen.

Source

Information sourced from the FDA Drug Shortage Database.