🇺🇸
United States · US · US:68462-319_891a4c1d-ed0c-4002-87d9-e395df0386d1
Ranolazine
Orange BookUNIISPLATC C01EB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeC01EB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116846231905500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-05)
- ndc11684623196060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-60)
Annotations
UNII (FDA Substance ID)
A6IEZ5M406
RANOLAZINE
RxCUI 35829
Orange Book
A211082
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": "68462-319_891a4c1d-ed0c-4002-87d9-e395df0386d1",
"productndc": "68462-319",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "211082",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jul 5, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Jul 5, 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": "ANDA211082",
"marketing_category": "ANDA",
"nonproprietary_name": "RANOLAZINE",
"start_marketing_date": "20190705",
"active_numerator_strength": "500"
}Related drugs
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