Cromolyn Sodium Concentrate (Gastrocrom) shortage

Cromolyn Sodium Concentrate (brand name Gastrocrom) is recorded by the U.S. Food and Drug Administration (FDA) with a shortage status of Current, covering 1 affected presentation across 1 strength, first posted 2023-11-03 and last updated 2026-08-20. Mylan Specialty, A Viatris Company is the single reporting company on this entry, filing 1 of the 1 source lines. The strengths listed are 20 mg/1 mL. 2 package NDCs are referenced, under 1 FDA application number and 1 substance identifier. The FDA files it under Pulmonary/Allergy. Of the 1 brand name shown, 1 was verified against RxNorm and 0 came from the FDA record. Every line is reproduced below with its company, presentation, package NDC and the FDA's own availability text, so each can be checked individually. Confirm the live status at the official FDA shortage record before relying on it: this page is regulatory supply information only, it is not medical advice, it does not assess clinical impact, and it never suggests a substitute.

Regulatory snapshot

FDA shortage status Current
Since (first posted) 2023-11-03
Last updated 2026-08-20
Affected presentations 1
Strengths listed 1 (20 mg/1 mL)
Reporting manufacturers 1
Brand names 1 (Gastrocrom)
Generic name Cromolyn Sodium Concentrate
Product form Concentrate
Therapeutic category Pulmonary/Allergy
Package NDCs listed 2
openFDA source rows 1
Official source https://www.accessdata.fda.gov/scripts/drugshortages/

Also known as

Cromolyn Sodium Concentrate is marketed under the brand name Gastrocrom. Brand names are never inferred on this site: each one below carries the source that vouches for it, so a name published by the FDA and a name resolved from the U.S. National Library of Medicine's RxNorm vocabulary can always be told apart. RxNorm mappings are resolved at ingestion time from the RxNorm concept identifiers openFDA publishes on the shortage record itself, and are accepted only when the brand concept's ingredient set matches the source product's exactly.

Brand nameSourceConcept identifierResolved
Gastrocrom RxNorm (NLM) RxCUI 217266 (BN) 2026-08-21

1 of 1 name(s) resolved through RxNorm; 0 taken from the FDA record itself.

Affected presentations, companies and availability

The FDA publishes one line per reported package presentation and reporting company. All 1 line(s) behind this entry are reproduced below — company, presentation, strength, package NDC, status, the agency's availability text verbatim, and the date each line was last updated — so any single line can be checked against the official record without leaving this page. No line becomes a page of its own.

Reporting companyPresentationStrengthPackage NDCStatusAvailability (FDA text)Updated
Mylan Specialty, A Viatris Company Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96) 20 mg/1 mL 0037-0678-96 Current Available 2026-08-20

FDA application number(s) recorded against the affected products: NDA020479. Substance identifier(s) (UNII): Q2WXR1I0PK.

Reporting manufacturers (1)

Each company below filed at least one of the source lines above. The record counts shown are coverage-limited activity signals from the indexed datasets — never quality ratings.

CompanyLines filed hereIndexed recordsRecallsShortage entries
Mylan Specialty, A Viatris Company 1 1 0 1

Related shortages

Every link below comes from a relation in the FDA data itself — a shared substance identifier, a shared reporting company, or a shared FDA therapeutic category — ordered by the strength of that overlap. Nothing here is a popularity list or an editorial suggestion.

Same FDA therapeutic category

How to interpret this shortage record

A drug-shortage entry means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. Because the FDA publishes one line per reported package and reporting company, this page consolidates 1 such line into the single shortage they describe; each line remains listed below with its own company, presentation and availability text so it can be checked individually against the source. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.

What an FDA shortage entry is

A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. It names the affected product, attributes the report to the companies shown above, and records a status marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The FDA publishes one line per reported package presentation and reporting company, so this entry is assembled from 1 such line rather than one page per line. The earliest initial posting date across them is 2023-11-03, and the latest update 2026-08-20. The FDA files this product under Pulmonary/Allergy in its own therapeutic categorisation, which is reproduced here as a source field and carries no clinical meaning on this page. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind.

Why this page has one address

This page's address is derived from the shortage's own identity — the product name as the FDA publishes it, including the form in which it is supplied — and not from the entry's status, from the reporting company, or from the order in which the openFDA API happened to return its rows. That means the address stays the same when the status changes from current to resolved, when another company is added to the same shortage, or when a further package presentation is reported. Distinct product forms of the same molecule — an injection and an oral capsule, say — remain distinct pages, because the FDA tracks them as separate shortages. 4 earlier addresses for this entry redirect here permanently, so previously published links continue to resolve.

What this record does not mean

This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

Source-row notes

Source-derived regulatory summary

The text in this section is generated from the FDA source fields shown elsewhere on this page. It is regulatory information only — not medical advice — and adds no facts beyond the official record.

This record pertains to Cromolyn Sodium Concentrate, marketed under the brand name Gastrocrom, in a concentration of 20 mg/1 mL. The product is currently available and is associated with Mylan Specialty, a Viatris Company. It is indicated for use in pulmonary and allergy-related conditions. The initial posting date of this record is November 3, 2023, with the last update scheduled for August 20, 2026.

Regulatory context

The status of 'Current' indicates that the product is actively marketed and available for use. The classification as 'Available' signifies that it can be obtained by consumers or healthcare providers. This information is regulatory in nature and does not imply any medical advice.

  • Drug shortage
  • Status: Current
  • Cromolyn Sodium Concentrate
  • Mylan Specialty, A Viatris Company

The summary utilized the fields: generic_name, status, presentation, availability, company_name, related_info, initial_posting_date, and last_updated_date. No fields were absent.

Where to go next

Source & provenance

Official source
https://www.accessdata.fda.gov/scripts/drugshortages/
Source dataset
openFDA Drug Shortages API
Publication date
2023-11-03
Ingested
2026-08-22
Record hash
242cebdea4d60850

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.