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FDA shortage status: Cromolyn Sodium Concentrate
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2023-11-03. Latest FDA row update: 2026-10-05.
FDA lists 6 package records, with companies: Ailex Pharmaceuticals, Micro Labs LTD, Micro Labs Limited, Mylan Specialty, a Viatris Company, Omnivium Pharmaceuticals LLC, Rising Pharma Holdings, Inc., Viatris Specialty LLC. Package NDCs: 0037-0678-96, 16571-600-96, 42571-132-52, 69784-200-96, 76204-025-96, 81665-104-96.
FDA shortage reason: Other
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Ailex Pharmaceuticals | 69784-200-96 | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 69784-200-96) | Limited Availability | 2026-09-30 |
| Ailex Pharmaceuticals | 76204-025-96 | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 76204-025-96) | Limited Availability | 2026-09-30 |
| Ailex Pharmaceuticals | 81665-104-96 | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 81665-104-96) | Available | 2026-09-30 |
| Micro Labs LTD | 42571-132-52 | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52) | Available | 2026-10-03 |
| Mylan Specialty, a Viatris Company | 0037-0678-96 | Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) | Available | 2026-10-05 |
| Rising Pharma Holdings, Inc. | 16571-600-96 | Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 16571-600-96) | Available | 2026-09-01 |
Source facts
Grouped generic ingredient: Cromolyn Sodium Concentrate · 6 package records
Therapeutic categories: Pulmonary/Allergy
Dosage forms: Concentrate
Routes: ORAL
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.