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United States · US · US:0093-6815_c51e584e-be7e-4807-aa09-ef3eca459a2f
Budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1100936815736 POUCH in 1 CARTON (0093-6815-73) / 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-6815-45) / 2 mL in 1 VIAL, SINGLE-DOSE (0093-6815-19)
- ndc1100936815762 POUCH in 1 CARTON (0093-6815-76) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A077519
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": "0093-6815_c51e584e-be7e-4807-aa09-ef3eca459a2f",
"productndc": "0093-6815",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "077519",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.25MG/2ML",
"product_no": "001",
"approval_date": "Nov 18, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "002",
"approval_date": "Nov 18, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "Budesonide",
"active_ingred_unit": "mg/2mL",
"application_number": "ANDA077519",
"marketing_category": "ANDA",
"nonproprietary_name": "Budesonide",
"start_marketing_date": "20081119",
"active_numerator_strength": ".25"
}Related drugs
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