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United States · US · US:62135-830_44fdbe83-0583-3b33-e063-6394a90a66db

Ipratropium Bromide

Orange BookUNIISPLATC R03BB01

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeR03BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213583084
    6 POUCH in 1 CARTON (62135-830-84) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
J697UZ2A9J
IPRATROPIUM BROMIDE
RxCUI 1309404
Orange Book
A075562
AN
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": {
    "52c63e41-dbbc-d9d7-e063-6294a90a30c9": {
      "match": "brand_token",
      "title": "IPRATROPIUM BROMIDE SOLUTION [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "62135-830_44fdbe83-0583-3b33-e063-6394a90a66db",
  "productndc": "62135-830",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075562",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.02%",
        "product_no": "001",
        "approval_date": "Sep 27, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IPRATROPIUM BROMIDE",
  "proprietary_name": "Ipratropium Bromide",
  "active_ingred_unit": "mg/2.5mL",
  "application_number": "ANDA075562",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium Bromide",
  "start_marketing_date": "20010927",
  "active_numerator_strength": ".5"
}

Related drugs

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