Ipratropium Bromide

Orange BookUNIISPLATC R03BB01

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

Identification

ManufacturerNephron Pharmaceuticals Corporation

CountryUS (United States)

ATC codeR03BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
0487980101
30 POUCH in 1 CARTON (0487-9801-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
0487980102
30 BAG in 1 BOX (0487-9801-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
0487980125
1 POUCH in 1 CARTON (0487-9801-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
0487980130
1 POUCH in 1 CARTON (0487-9801-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
ndc11
0487980160
2 POUCH in 1 CARTON (0487-9801-60) / 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

A075562

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": "0487-9801_3249e47e-0ac1-e2a5-e063-6394a90a9993",
  "productndc": "0487-9801",
  "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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