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United States · US · US:73043-052_8f1bd281-a307-4e2c-8796-6b55495bd3e2

Arformoterol Tartrate Inhalation

Orange BookUNIISPL

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

Identification

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

Packs · 2

  • ndc11
    7304305260
    60 POUCH in 1 CARTON (73043-052-60) / 4 VIAL in 1 POUCH (73043-052-04) / 2 mL in 1 VIAL
  • ndc11
    7304305293
    30 POUCH in 1 CARTON (73043-052-93) / 1 VIAL in 1 POUCH (73043-052-01) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
5P8VJ2I235
ARFORMOTEROL TARTRATE
RxCUI 668284
Orange Book
A218429
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": "73043-052_8f1bd281-a307-4e2c-8796-6b55495bd3e2",
  "productndc": "73043-052",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "218429",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "Apr 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARFORMOTEROL TARTRATE",
  "proprietary_name": "Arformoterol Tartrate Inhalation",
  "active_ingred_unit": "ug/2mL",
  "application_number": "ANDA218429",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arformoterol Tartrate Inhalation",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "15"
}

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