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Cromolyn Sodium Concentrate shortage

Current  6 presentations · 4 manufacturers · first FDA posting 2023-11-03 · last update 2026-10-05

Manufacturers: Ailex Pharmaceuticals, Micro Labs LTD, Mylan Specialty, a Viatris Company, Rising Pharma Holdings, Inc.

Stated reasons (per FDA): Other

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Presentations

PresentationManufacturerStatusReasonNotes (FDA)Dates
Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 69784-200-96)Ailex PharmaceuticalsCurrent
Limited Availability
OtherNo longer manufactured, some supplies still available in supply chain. Distributed by Woodward Pharma Services LLC (248) 308-1120 Ext 2Posted 11/03/2023
Updated 09/30/2026
Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 76204-025-96)Ailex PharmaceuticalsCurrent
Limited Availability
OtherNo longer manufactured, some supplies still available in supply chain. Distributed by Ritedose Pharmaceuticals, LLC (855) 806 3300Posted 11/03/2023
Updated 09/30/2026
Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96)Ailex PharmaceuticalsCurrent
Available
—Distributed by Omnivium Pharmaceuticals LLC (888) 807-9195Posted 11/03/2023
Updated 09/30/2026
Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52)Micro Labs LTDCurrent
Available
—Posted 11/03/2023
Updated 10/03/2026
Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96)Mylan Specialty, a Viatris CompanyCurrent
Available
—Posted 11/03/2023
Updated 10/05/2026
Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 16571-600-96)Rising Pharma Holdings, Inc.Current
Available
—Posted 11/03/2023
Updated 09/01/2026

Source: FDA Drug Shortages Database · raw openFDA records

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