Medicine
Cromolyn 100 mg/5 mL oral concentrate
Cromolyn 100 mg/5 mL oral concentrate is a generic prescription medicine for oral use, made by 3 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store ampules in foil pouch until ready for use.
Key facts
- Active ingredient (INN)
- Cromolyn
- Brand
- Sold under the generic name
- Strength
- 100 mg/5 mL
- Dosage form
- Oral concentrate
- Route
- Oral
- Packs
- 96 cartons, 12 pouches
- Manufacturers
- Micro LabsIndiaOmnivium PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store ampules in foil pouch until ready for use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07EB01 Cromolyn
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 December 2011
- Identifiers
- RxCUI 831261DailyMed set ID 93f80edb-3b38-423e-8cd6-5b5cb4393ec2, a742664b-265e-49f9-9744-d04e1fb620ae, 61c9cb85-129e-4490-b5f7-357307fcecbfNDC 42571-132, 81665-104, 16571-600Application ANDA202745, ANDA209264, ANDA202583
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 96 carton in 1 carton / 1 tray in 1 carton / 8 ampule in 1 tray / 5 mL in 1 ampule | 42571-132-52 | Micro LabsIndia | 4 May 2013 |
| 12 pouch in 1 carton / 8 ampule in 1 pouch / 5 mL in 1 ampule | 81665-104-96 | Omnivium Pharmaceuticals | 31 August 2024 |
| 12 pouch in 1 carton / 8 ampule in 1 pouch / 5 mL in 1 ampule | 16571-600-96 | Rising Pharma Holdings | 5 December 2011 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 28 May 1982 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Cromolyn
Clinical summary
Cromolyn is a mast cell stabilizer indicated in the management of patients with mastocytosis. It is available as eye drops, oral concentrate and oral liquid for ophthalmic and intrabronchial use. MedsAcross supplies Cromolyn for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about CromolynFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gastrocrom prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Cromolyn 100 mg/5 mL oral concentrate for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.