🇺🇸
United States · US · US:76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14
Cromolyn Sodium Inhalation Solution
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
- ndc1176204028602 POUCH in 1 CARTON (76204-028-60) / 30 AMPULE in 1 POUCH (76204-028-12) / 2 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A209453
AN
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": "RESPIRATORY (INHALATION)",
"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": "76204-028_459fa0f5-35dd-d6e5-e063-6394a90a6f14",
"productndc": "76204-028",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "209453",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "10MG/ML",
"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 Inhalation Solution",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA209453",
"marketing_category": "ANDA",
"nonproprietary_name": "Cromolyn Sodium Inhalation Solution",
"start_marketing_date": "20211201",
"active_numerator_strength": "20"
}Related drugs
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