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United States · US · US:0115-1687_dbb6c949-66b1-4f60-ab96-442dd8b4ea19
Budesonide Inhalation
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101151687746 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A078404
ANAN
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Q3OKS62Q6X",
"rxcui": "19831",
"inchikey": "VOVIALXJUBGFJZ-KWVAZRHASA-N",
"display_name": "BUDESONIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"dd352302-e2fe-4388-b4b0-00b34f6ebe48": {
"match": "brand_token",
"title": "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE AEROSOL, METERED [TEVA PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-29"
}
},
"productid": "0115-1687_dbb6c949-66b1-4f60-ab96-442dd8b4ea19",
"productndc": "0115-1687",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "078404",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.25MG/2ML",
"product_no": "001",
"approval_date": "Jul 31, 2012"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Jul 31, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide Inhalation",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA078404",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20160804",
"active_numerator_strength": ".25"
}Related drugs
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