🇺🇸
United States · US · US:16571-600_ca2c72ae-db00-4694-9fd0-d4b6b45f8108
CROMOLYN SODIUM
In shortageOrange BookUNIISPLATC R03BC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeR03BC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11165716009612 POUCH in 1 CARTON (16571-600-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A202583
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": "16571-600_ca2c72ae-db00-4694-9fd0-d4b6b45f8108",
"productndc": "16571-600",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "202583",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Oct 27, 2011"
}
],
"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/5mL",
"application_number": "ANDA202583",
"marketing_category": "ANDA",
"nonproprietary_name": "CROMOLYN SODIUM",
"start_marketing_date": "20111205",
"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 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.