🇺🇸
United States · US · US:51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903
cromolyn sodium
In shortageOrange BookUNIISPLATC R03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11515250470912 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 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": {
"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": "51525-0470_b70d4285-ddb4-4e80-baf1-340f9572d903",
"productndc": "51525-0470",
"dosage_form": "SOLUTION",
"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": "cromolyn sodium",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA020479",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "cromolyn sodium",
"start_marketing_date": "20151021",
"active_numerator_strength": "100"
}Related drugs
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