🇺🇸
United States · US · US:68788-8503_3b3a9e87-3f6a-4168-a2bc-04feee0ae479
budesonide inhalation
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168788850336 POUCH in 1 CARTON (68788-8503-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A210897
AN
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": "68788-8503_3b3a9e87-3f6a-4168-a2bc-04feee0ae479",
"productndc": "68788-8503",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "210897",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AN",
"strength": "0.5MG/2ML",
"product_no": "001",
"approval_date": "Nov 9, 2018"
}
],
"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": "ANDA210897",
"marketing_category": "ANDA",
"nonproprietary_name": "budesonide inhalation",
"start_marketing_date": "20230809",
"active_numerator_strength": ".5"
}Related drugs
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