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United States · US · US:24338-017_9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04
BRYNOVIN
Orange BookUNIISPLATC A10BH01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA10BH01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124338017011 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
QFP0P1DV7Z
SITAGLIPTIN
RxCUI 593411
Orange Book
N219122
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QFP0P1DV7Z",
"rxcui": "593411",
"inchikey": "MFFMDFFZMYYVKS-SECBINFHSA-N",
"display_name": "SITAGLIPTIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04": {
"match": "brand_token",
"title": "BRYNOVIN (SITAGLIPTIN HYDROCHLORIDE ORAL) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2025-06-11"
}
},
"productid": "24338-017_9468a2f3-3ebe-40bd-a3b4-d78d9eb47e04",
"productndc": "24338-017",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "219122",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 25MG BASE/ML",
"product_no": "001",
"approval_date": "Jan 16, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SITAGLIPTIN",
"proprietary_name": "BRYNOVIN",
"active_ingred_unit": "mg/mL",
"application_number": "NDA219122",
"marketing_category": "NDA",
"nonproprietary_name": "Sitagliptin Hydrochloride Oral",
"start_marketing_date": "20250401",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code A10BH01.
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