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United States · US · US:60687-770_04b2262f-ade9-c53b-e063-6294a90a3610

Arformoterol Tartrate

Orange BookUNIISPL

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6068777083
    30 POUCH in 1 CARTON (60687-770-83) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79)
  • ndc11
    6068777084
    60 POUCH in 1 CARTON (60687-770-84) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE (60687-770-79)

Annotations

UNII (FDA Substance ID)
5P8VJ2I235
ARFORMOTEROL TARTRATE
RxCUI 668284
Orange Book
A215385
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": "60687-770_04b2262f-ade9-c53b-e063-6294a90a3610",
  "productndc": "60687-770",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "215385",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.015MG BASE/2ML",
        "product_no": "001",
        "approval_date": "May 26, 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": "ANDA215385",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Arformoterol Tartrate",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "15"
}

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