🇺🇸
United States · US · US:0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d
Gastrocrom
In shortageOrange BookUNIISPLATC R03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeR03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11003706789612 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
N020479
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": {
"00623958-a8fe-47d1-a0d2-0aa4e2f7966e": {
"match": "brand_token",
"title": "GASTROCROM (CROMOLYN SODIUM) LIQUID [VIATRIS SPECIALTY LLC]",
"spl_version": "6",
"published_date": "2025-08-22"
}
},
"productid": "0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04d",
"productndc": "0037-0678",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "020479",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Feb 29, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CROMOLYN SODIUM",
"shortage_reason": "Cromolyn Sodium Concentrate",
"shortage_status": "current",
"proprietary_name": "Gastrocrom",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020479",
"marketing_category": "NDA",
"nonproprietary_name": "cromolyn sodium",
"start_marketing_date": "20150501",
"active_numerator_strength": "20"
}Related drugs
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