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United States · US · US:70756-612_0cf1c98c-4caf-4eff-b603-6c4b8dd6e148

arformoterol tartrate

Orange BookUNIISPL

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

Identification

ManufacturerLifestar Pharma LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7075661260
    60 POUCH in 1 CARTON (70756-612-60) / 4 VIAL in 1 POUCH (70756-612-44) / 2 mL in 1 VIAL
  • ndc11
    7075661270
    30 POUCH in 1 CARTON (70756-612-70) / 1 VIAL in 1 POUCH (70756-612-12) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
5P8VJ2I235
ARFORMOTEROL TARTRATE
RxCUI 668284
Orange Book
A216128
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": "70756-612_0cf1c98c-4caf-4eff-b603-6c4b8dd6e148",
  "productndc": "70756-612",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "216128",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "Nov 15, 2022"
      }
    ],
    "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": "ANDA216128",
  "marketing_category": "ANDA",
  "nonproprietary_name": "arformoterol tartrate",
  "start_marketing_date": "20221115",
  "active_numerator_strength": "15"
}

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