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United States · US · US:52652-6001_461e773b-ccc2-532d-e063-6294a90abad9
FLEQSUVY
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1152652600111 BOTTLE in 1 CARTON (52652-6001-1) / 120 mL in 1 BOTTLE
- ndc1152652600121 BOTTLE in 1 CARTON (52652-6001-2) / 300 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
N215602
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H789N3FKE8",
"rxcui": "1292",
"inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
"display_name": "BACLOFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa": {
"match": "brand_token",
"title": "FLEQSUVY (BACLOFEN) SUSPENSION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "4",
"published_date": "2025-12-18"
}
},
"productid": "52652-6001_461e773b-ccc2-532d-e063-6294a90abad9",
"productndc": "52652-6001",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "215602",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "25MG/5ML",
"product_no": "001",
"approval_date": "Feb 4, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "FLEQSUVY",
"active_ingred_unit": "mg/mL",
"application_number": "NDA215602",
"marketing_category": "NDA",
"nonproprietary_name": "baclofen",
"start_marketing_date": "20220207",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M03BX01.
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