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United States · US · US:42571-132_22ffea9c-cd39-22dd-e063-6394a90aae4b

CROMOLYN SODIUM

In shortageOrange BookUNIISPLATC R03BC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeR03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4257113252
    96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21)

Annotations

UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A202745
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": "42571-132_22ffea9c-cd39-22dd-e063-6394a90aae4b",
  "productndc": "42571-132",
  "dosage_form": "SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "202745",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Apr 4, 2013"
      }
    ],
    "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": "ANDA202745",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cromolyn sodium",
  "start_marketing_date": "20130504",
  "active_numerator_strength": "100"
}

Related drugs

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