Arformoterol Tartrate Inhalation Solution

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAucta Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7328900723
30 POUCH in 1 CARTON (73289-0072-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-1) / 2 mL in 1 VIAL, SINGLE-DOSE
ndc11
7328900724
15 POUCH in 1 CARTON (73289-0072-4) / 4 VIAL, SINGLE-DOSE in 1 POUCH (73289-0072-2) / 2 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

5P8VJ2I235

ARFORMOTEROL TARTRATE

RxCUI 668284

Orange Book

A218380

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": "73289-0072_2de3ae20-a1ec-6be3-e063-6294a90af05a",
  "productndc": "73289-0072",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "218380",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "Feb 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ARFORMOTEROL TARTRATE",
  "proprietary_name": "Arformoterol Tartrate Inhalation Solution",
  "active_ingred_unit": "ug/2mL",
  "application_number": "ANDA218380",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arformoterol Tartrate",
  "start_marketing_date": "20250211",
  "active_numerator_strength": "15"
}

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