🇺🇸
United States · US · US:76204-025_459fa806-53ad-d48e-e063-6394a90af72b
Cromolyn Sodium Oral Solution (Concentrate)
In shortageOrange BookUNIISPLATC R03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRitedose Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11762040259612 POUCH in 1 CARTON (76204-025-96) / 8 AMPULE in 1 POUCH (76204-025-08) / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A209264
AA
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Cromolyn Sodium Concentrate
Raw payload (JSON)
{
"unii": {
"unii": "Q2WXR1I0PK",
"rxcui": "3538",
"inchikey": "VLARUOGDXDTHEH-UHFFFAOYSA-L",
"display_name": "CROMOLYN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"18892411-465f-4d8d-9550-7dafa6c6a0a3": {
"match": "brand_token",
"title": "CROMOLYN SODIUM SOLUTION/ DROPS [PREFERRED PHARMACEUTICALS INC.]",
"spl_version": "5",
"published_date": "2026-04-02"
}
},
"productid": "76204-025_459fa806-53ad-d48e-e063-6394a90af72b",
"productndc": "76204-025",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "209264",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Oct 16, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CROMOLYN SODIUM",
"shortage_reason": "Cromolyn Sodium Concentrate",
"shortage_status": "current",
"proprietary_name": "Cromolyn Sodium Oral Solution (Concentrate)",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA209264",
"marketing_category": "ANDA",
"nonproprietary_name": "Cromolyn Sodium Oral Solution (Concentrate)",
"start_marketing_date": "20211201",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code R03BC01.
- FIBlacilOrion Corporation Orion Pharma
- FIBlacilOrion Corporation Orion Pharma
- 🇫🇷CROMOGLICATE DE SODIUM BIOGARAN 2 %, collyre en solutionBIOGARAN
- 🇫🇷CROMOGLICATE DE SODIUM VIATRIS 2 %, collyre en solutionVIATRIS SANTE
- 🇺🇸cromolyn sodiumMylan Pharmaceuticals Inc.
- 🇺🇸Cromolyn SodiumTeva Pharmaceuticals USA, Inc.
- 🇺🇸Cromolyn SodiumA-S Medication Solutions
- 🇺🇸Cromolyn SodiumSandoz Inc
Access this data programmatically
Query Cromolyn Sodium Oral Solution (Concentrate) and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.