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United States · US · US:68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1
Ipratroprium Bromide
Orange BookUNIISPLATC R03BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeR03BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168682398301 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY
Annotations
UNII (FDA Substance ID)
J697UZ2A9J
IPRATROPIUM BROMIDE
RxCUI 1309404
Orange Book
A076025
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": {
"40e37c2f-a2c0-419b-8451-1aa0458bc420": {
"match": "brand_token",
"title": "IPRATROPRIUM BROMIDE SPRAY, METERED [OCEANSIDE PHARMACEUTICALS]",
"spl_version": "7",
"published_date": "2025-08-08"
}
},
"productid": "68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1",
"productndc": "68682-398",
"dosage_form": "SPRAY, METERED",
"orange_book": {
"appl_no": "076025",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.021MG/SPRAY",
"product_no": "001",
"approval_date": "Mar 31, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IPRATROPIUM BROMIDE",
"proprietary_name": "Ipratroprium Bromide",
"active_ingred_unit": "ug/1",
"application_number": "ANDA076025",
"marketing_category": "ANDA",
"nonproprietary_name": "Ipratroprium Bromide",
"start_marketing_date": "20250601",
"active_numerator_strength": "21"
}Related drugs
Other records sharing ATC code R03BB01.
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