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United States · US · US:68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648
budesonide
Orange BookUNIISPLATC A07EA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA07EA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838272001100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01)
- ndc116838272005500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05)
- ndc11683827200630 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06)
- ndc1168382720101000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10)
- ndc11683827201690 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16)
- ndc11683827207710 BLISTER PACK in 1 CARTON (68382-720-77) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)
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": "68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648",
"productndc": "68382-720",
"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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