🇺🇸
United States · US · US:47335-756_c0e6d8e4-e189-480c-8a4c-f52dda4c6dc5
Ipratropium Bromide and Albuterol Sulfate
In shortageOrange BookUNIISPLATC R03AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1147335756496 POUCH in 1 CARTON (47335-756-49) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
- ndc11473357565212 POUCH in 1 CARTON (47335-756-52) / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A207875
AN
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Albuterol Sulfate Solution
Raw payload (JSON)
{
"unii": {
"unii": "021SEF3731",
"rxcui": "142153",
"inchikey": "BNPSSFBOAGDEEL-UHFFFAOYSA-N",
"display_name": "ALBUTEROL SULFATE",
"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": "47335-756_c0e6d8e4-e189-480c-8a4c-f52dda4c6dc5",
"productndc": "47335-756",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207875",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.083% BASE;0.017%",
"product_no": "001",
"approval_date": "Aug 7, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
"shortage_reason": "Albuterol Sulfate Solution",
"shortage_status": "current",
"proprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
"active_ingred_unit": "mg/3mL; mg/3mL",
"application_number": "ANDA207875",
"marketing_category": "ANDA",
"nonproprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
"start_marketing_date": "20211115",
"active_numerator_strength": "2.5; .5"
}Related drugs
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