🇺🇸
United States · US · US:61314-237_4d6f900a-fa36-445e-80d5-54c8cc5baf34
Cromolyn Sodium
In shortageOrange BookUNIISPLATC R03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeR03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11613142371010 mL in 1 BOTTLE, PLASTIC (61314-237-10)
Annotations
UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A075282
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": "OPHTHALMIC",
"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": "61314-237_4d6f900a-fa36-445e-80d5-54c8cc5baf34",
"productndc": "61314-237",
"dosage_form": "SOLUTION/ DROPS",
"orange_book": {
"appl_no": "075282",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "4%",
"product_no": "001",
"approval_date": "Jun 16, 1999"
}
],
"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",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA075282",
"marketing_category": "ANDA",
"nonproprietary_name": "Cromolyn Sodium",
"start_marketing_date": "19990629",
"active_numerator_strength": "40"
}Related drugs
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