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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

  • ndc11
    6846231905
    500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-319-05)
  • ndc11
    6846231960
    60 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"
}

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