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United States · US · US:70771-1075_bfde9c2e-2ff5-4258-91bc-78a48b228d14
budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1170771107501000 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-0)
- ndc117077110751100 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-1)
- ndc11707711075330 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-3)
- ndc11707711075410 BLISTER PACK in 1 CARTON (70771-1075-4) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
- ndc117077110755500 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-5)
- ndc11707711075990 CAPSULE, COATED PELLETS in 1 BOTTLE (70771-1075-9)
Annotations
UNII (FDA Substance ID)
Q3OKS62Q6X
BUDESONIDE
RxCUI 19831
Orange Book
A206134
AB
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": "ORAL",
"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": "70771-1075_bfde9c2e-2ff5-4258-91bc-78a48b228d14",
"productndc": "70771-1075",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "206134",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "3MG",
"product_no": "001",
"approval_date": "May 4, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUDESONIDE",
"proprietary_name": "budesonide",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206134",
"marketing_category": "ANDA",
"nonproprietary_name": "budesonide",
"start_marketing_date": "20170608",
"active_numerator_strength": "3"
}Related drugs
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