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United States · US · US:0172-6406_38833b9a-b1dd-4e33-b8a3-806fa99eb4a4

Cromolyn Sodium

In shortageOrange BookUNIISPLATC R03BC01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeR03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0172640649
    12 POUCH in 1 CARTON (0172-6406-49) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0172-6406-05) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A075271
AN
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": "INTRABRONCHIAL",
  "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": "0172-6406_38833b9a-b1dd-4e33-b8a3-806fa99eb4a4",
  "productndc": "0172-6406",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075271",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jan 18, 2000"
      }
    ],
    "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/2mL",
  "application_number": "ANDA075271",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cromolyn Sodium",
  "start_marketing_date": "20000118",
  "active_numerator_strength": "20"
}

Related drugs

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