Ipratropium bromide

Orange BookUNIISPLATC R03BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeR03BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6586290503
30 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
6586290525
1 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
6586290530
1 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
6586290560
2 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

J697UZ2A9J

IPRATROPIUM BROMIDE

RxCUI 1309404

Orange Book

A206543

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": "65862-905_08eada61-404a-b5f8-e063-6294a90a74e7",
  "productndc": "65862-905",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "206543",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "0.02%",
        "product_no": "001",
        "approval_date": "Oct 27, 2016"
      }
    ],
    "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": "ANDA206543",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium bromide",
  "start_marketing_date": "20161027",
  "active_numerator_strength": ".5"
}

Related drugs

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