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United States · US · US:0597-0087_73904f10-4e08-4277-adf6-b605468eb05e

Atrovent

Orange BookUNIISPLATC R03BB01

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0597008717
    1 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER

Annotations

UNII (FDA Substance ID)
J697UZ2A9J
IPRATROPIUM BROMIDE
RxCUI 1309404
Orange Book
N021527
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "J697UZ2A9J",
    "rxcui": "1309404",
    "inchikey": "KEWHKYJURDBRMN-ZSSLXWFGSA-M;KEWHKYJURDBRMN-FBORWGRJSA-M",
    "display_name": "IPRATROPIUM BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "170e98ef-5560-4068-be7d-e649068eb884": {
      "match": "brand_token",
      "title": "ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "21",
      "published_date": "2025-11-18"
    }
  },
  "productid": "0597-0087_73904f10-4e08-4277-adf6-b605468eb05e",
  "productndc": "0597-0087",
  "dosage_form": "AEROSOL, METERED",
  "orange_book": {
    "appl_no": "021527",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.021MG/INH",
        "product_no": "001",
        "approval_date": "Nov 27, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IPRATROPIUM BROMIDE",
  "proprietary_name": "Atrovent",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021527",
  "marketing_category": "NDA",
  "nonproprietary_name": "ipratropium bromide",
  "start_marketing_date": "20050501",
  "active_numerator_strength": "17"
}

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