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United States · US · US:72266-259_2aba8bac-6807-dca1-e063-6394a90a01f0

Arformoterol tartrate

Orange BookUNIISPL

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

Identification

ManufacturerFosun Pharma USA Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7226625930
    30 POUCH in 1 CARTON (72266-259-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (72266-259-01) / 2 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7226625960
    15 POUCH in 1 CARTON (72266-259-60) / 4 VIAL, SINGLE-DOSE in 1 POUCH (72266-259-04) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
5P8VJ2I235
ARFORMOTEROL TARTRATE
RxCUI 668284
Orange Book
A214901
AN
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5P8VJ2I235",
    "rxcui": "668284",
    "inchikey": "FCSXYHUNDAXDRH-OKMNHOJOSA-N",
    "display_name": "ARFORMOTEROL TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "f1005878-0c48-4b9a-843e-b6cf6b8bb251": {
      "match": "brand_token",
      "title": "ARFORMOTEROL TARTRATE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "4",
      "published_date": "2026-04-15"
    }
  },
  "productid": "72266-259_2aba8bac-6807-dca1-e063-6394a90a01f0",
  "productndc": "72266-259",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "214901",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "Apr 2, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARFORMOTEROL TARTRATE",
  "proprietary_name": "Arformoterol tartrate",
  "active_ingred_unit": "ug/2mL",
  "application_number": "ANDA214901",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arformoterol tartrate",
  "start_marketing_date": "20250120",
  "active_numerator_strength": "15"
}

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