Ipratropium Bromide

Orange BookUNIISPLATC R03BB01

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

Identification

ManufacturerRitedose Pharmaceuticals, LLC

CountryUS (United States)

ATC codeR03BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7620410001
30 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
ndc11
7620410025
1 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
ndc11
7620410030
1 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE
ndc11
7620410060
2 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

J697UZ2A9J

IPRATROPIUM BROMIDE

RxCUI 1309404

Orange Book

A075693

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": "76204-100_459b984d-b299-c7c0-e063-6294a90a3efd",
  "productndc": "76204-100",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075693",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "0.02%",
        "product_no": "001",
        "approval_date": "Jan 26, 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": "ANDA075693",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ipratropium Bromide",
  "start_marketing_date": "20110201",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code R03BB01.

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