🇺🇸
United States · US · US:0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa
Ipratropium Bromide and Albuterol Sulfate
In shortageOrange BookUNIISPLATC R03AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1103789671301 POUCH in 1 CARTON (0378-9671-30) / 30 AMPULE in 1 POUCH (0378-9671-64) / 3 mL in 1 AMPULE
- ndc1103789671602 POUCH in 1 CARTON (0378-9671-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
- ndc11037896719330 POUCH in 1 CARTON (0378-9671-93) / 1 AMPULE in 1 POUCH (0378-9671-31) / 3 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A202496
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": "0378-9671_96603d2c-6783-4f6c-8b3e-de3eaabcc6aa",
"productndc": "0378-9671",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "202496",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "EQ 0.083% BASE;0.017%",
"product_no": "001",
"approval_date": "Oct 1, 2012"
}
],
"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": "ANDA202496",
"marketing_category": "ANDA",
"nonproprietary_name": "Ipratropium Bromide and Albuterol Sulfate",
"start_marketing_date": "20130301",
"active_numerator_strength": "2.5; .5"
}Related drugs
Other records sharing ATC code R03AC.
- 🇺🇸AIRSUPRAAstraZeneca Pharmaceuticals LP
- GBAtectura Breezhaler 125micrograms/127.5micrograms inhalation powder capsules with deviceNovartis Pharmaceuticals UK Ltd
- GBAtectura Breezhaler 125micrograms/260micrograms inhalation powder capsules with deviceNovartis Pharmaceuticals UK Ltd
- GBAtectura Breezhaler 125micrograms/62.5micrograms inhalation powder capsules with deviceNovartis Pharmaceuticals UK Ltd
- 🇺🇸BEVESPI AEROSPHEREAstraZeneca Pharmaceuticals LP
- GBBibecfo 100micrograms/dose / 6micrograms/dose inhalerCipla EU Ltd
- GBBibecfo 200micrograms/dose / 6micrograms/dose inhalerCipla EU Ltd
- 🇺🇸Combivent RespimatBoehringer Ingelheim Pharmaceuticals, Inc.
Access this data programmatically
Query Ipratropium Bromide and Albuterol Sulfate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.