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United States · US · US:69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637
Ipratropium Bromide
Orange BookUNIISPLATC R03BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeR03BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169238201631 BOTTLE, SPRAY in 1 CARTON (69238-2016-3) / 345 SPRAY in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
J697UZ2A9J
IPRATROPIUM BROMIDE
RxCUI 1309404
Orange Book
A215104
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": "NASAL",
"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": "69238-2016_1c1d7d62-9ebf-49eb-9eb2-471f9ce73637",
"productndc": "69238-2016",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "215104",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.021MG/SPRAY",
"product_no": "001",
"approval_date": "Aug 16, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IPRATROPIUM BROMIDE",
"proprietary_name": "Ipratropium Bromide",
"active_ingred_unit": "ug/1",
"application_number": "ANDA215104",
"marketing_category": "ANDA",
"nonproprietary_name": "Ipratropium Bromide",
"start_marketing_date": "20220818",
"active_numerator_strength": "21"
}Related drugs
Other records sharing ATC code R03BB01.
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