🇺🇸
United States · US · US:29300-296_429d55c7-1e90-4345-a6d4-59f689557f40
Ranolazine
Orange BookUNIISPLATC C01EB18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeC01EB18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112930029601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-01)
- ndc112930029605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-05)
- ndc11293002961660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-16)
Annotations
UNII (FDA Substance ID)
A6IEZ5M406
RANOLAZINE
RxCUI 35829
Orange Book
A213083
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": "29300-296_429d55c7-1e90-4345-a6d4-59f689557f40",
"productndc": "29300-296",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213083",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Mar 16, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1GM",
"product_no": "002",
"approval_date": "Mar 16, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RANOLAZINE",
"proprietary_name": "Ranolazine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213083",
"marketing_category": "ANDA",
"nonproprietary_name": "Ranolazine",
"start_marketing_date": "20230316",
"active_numerator_strength": "500"
}Related drugs
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