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United States · US · US:71610-971_45236b92-015e-16d3-e063-6394a90a1068
RANOLAZINE
Orange BookUNIISPLATC C01EB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC01EB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171610971421800 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-971-42)
Annotations
UNII (FDA Substance ID)
A6IEZ5M406
RANOLAZINE
RxCUI 35829
Orange Book
A211829
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "A6IEZ5M406",
"rxcui": "35829",
"inchikey": "XKLMZUWKNUAPSZ-UHFFFAOYSA-N",
"display_name": "RANOLAZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d2454377-2abd-4d9f-85f1-12f1adbb10e5": {
"match": "brand_token",
"title": "RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [TORRENT PHARMA, INC.]",
"spl_version": "1",
"published_date": "2026-05-12"
}
},
"productid": "71610-971_45236b92-015e-16d3-e063-6394a90a1068",
"productndc": "71610-971",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211829",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jun 4, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Jun 4, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RANOLAZINE",
"proprietary_name": "RANOLAZINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211829",
"marketing_category": "ANDA",
"nonproprietary_name": "RANOLAZINE",
"start_marketing_date": "20250630",
"active_numerator_strength": "500"
}Related drugs
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