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United States · US · US:47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d
Ipratropium Bromide
Orange BookUNIISPLATC R03BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR03BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1147335706495 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL
- ndc1147335706526 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
- ndc11473357065412 POUCH in 1 CARTON (47335-706-54) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
J697UZ2A9J
IPRATROPIUM BROMIDE
RxCUI 1309404
Orange Book
A207903
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": "47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d",
"productndc": "47335-706",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207903",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.02%",
"product_no": "001",
"approval_date": "Jan 3, 2017"
}
],
"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": "ANDA207903",
"marketing_category": "ANDA",
"nonproprietary_name": "Ipratropium Bromide",
"start_marketing_date": "20200204",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code R03BB01.
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