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United States · US · US:49502-605_4607ec7c-6203-4e4b-877f-c6cb03c15590

Perforomist

Orange BookUNIISPLATC R03AC13

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeR03AC13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4950260530
    30 POUCH in 1 CARTON (49502-605-30) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
  • ndc11
    4950260561
    60 POUCH in 1 CARTON (49502-605-61) / 1 VIAL in 1 POUCH (49502-605-95) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
W34SHF8J2K
FORMOTEROL FUMARATE
RxCUI 998038
Orange Book
N022007
AN
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "W34SHF8J2K",
    "rxcui": "998038",
    "inchikey": "RATSWNOMCHFQGJ-TUYNVFRMSA-N;RATSWNOMCHFQGJ-AYJOUMQSSA-N",
    "display_name": "FORMOTEROL FUMARATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "fb2fe258-fe2e-47f6-8adf-ca75bf6f90af": {
      "match": "brand_token",
      "title": "PERFOROMIST (FORMOTEROL FUMARATE DIHYDRATE) SOLUTION [VIATRIS SPECIALTY LLC]",
      "spl_version": "22",
      "published_date": "2025-02-13"
    }
  },
  "productid": "49502-605_4607ec7c-6203-4e4b-877f-c6cb03c15590",
  "productndc": "49502-605",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "022007",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AN",
        "strength": "0.02MG/2ML",
        "product_no": "001",
        "approval_date": "May 11, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FORMOTEROL FUMARATE",
  "proprietary_name": "Perforomist",
  "active_ingred_unit": "ug/2mL",
  "application_number": "NDA022007",
  "marketing_category": "NDA",
  "nonproprietary_name": "formoterol fumarate dihydrate",
  "start_marketing_date": "20071001",
  "active_numerator_strength": "20"
}

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