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United States · US · US:70436-151_3bd6ebed-0405-445a-8613-ae20b2e70703

Arformoterol Tartrate Inhalation

Orange BookUNIISPL

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

Identification

ManufacturerSlate Run Pharmaceuticals
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7043615157
    30 POUCH in 1 CARTON (70436-151-57) / 1 VIAL in 1 POUCH (70436-151-19) / 2 mL in 1 VIAL
  • ndc11
    7043615158
    15 POUCH in 1 CARTON (70436-151-58) / 4 VIAL in 1 POUCH (70436-151-20) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
5P8VJ2I235
ARFORMOTEROL TARTRATE
RxCUI 668284
Orange Book
A213762
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": "70436-151_3bd6ebed-0405-445a-8613-ae20b2e70703",
  "productndc": "70436-151",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "213762",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "Jun 22, 2021"
      }
    ],
    "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": "ANDA213762",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arformoterol Tartrate Inhalation",
  "start_marketing_date": "20210622",
  "active_numerator_strength": "15"
}

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