🇺🇸
United States · US · US:72865-312_c4dddf41-2e19-4fd1-8f2a-6b33a804ed40
Sacubitril and Valsartan
Orange BookUNIISPLATC C09DX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXLCare Pharmaceuticals Inc
CountryUS (United States)
ATC codeC09DX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1172865312101000 TABLET in 1 BOTTLE (72865-312-10)
- ndc117286531218180 TABLET in 1 BOTTLE (72865-312-18)
- ndc11728653126060 TABLET in 1 BOTTLE (72865-312-60)
Annotations
UNII (FDA Substance ID)
17ERJ0MKGI
SACUBITRIL
RxCUI 1656328
Orange Book
A213728
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "17ERJ0MKGI",
"rxcui": "1656328",
"inchikey": "PYNXFZCZUAOOQC-UTKZUKDTSA-N",
"display_name": "SACUBITRIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a1fa7066-8ab4-47e3-a701-6c5170700d11": {
"match": "brand_token",
"title": "SACUBITRIL AND VALSARTAN TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "72865-312_c4dddf41-2e19-4fd1-8f2a-6b33a804ed40",
"productndc": "72865-312",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213728",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "24MG;26MG",
"product_no": "001",
"approval_date": "Oct 16, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "49MG;51MG",
"product_no": "002",
"approval_date": "Oct 16, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "97MG;103MG",
"product_no": "003",
"approval_date": "Oct 16, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SACUBITRIL; VALSARTAN",
"proprietary_name": "Sacubitril and Valsartan",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213728",
"marketing_category": "ANDA",
"nonproprietary_name": "Sacubitril and Valsartan",
"start_marketing_date": "20250930",
"active_numerator_strength": "97; 103"
}Related drugs
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