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United States · US · US:27241-125_933f695e-e4f4-4c75-80fc-aea9a30aa13d

Ranolazine

Orange BookUNIISPLATC C01EB18

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeC01EB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2724112502
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-125-02)
  • ndc11
    2724112505
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-125-05)

Annotations

UNII (FDA Substance ID)
A6IEZ5M406
RANOLAZINE
RxCUI 35829
Orange Book
A210054
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": "27241-125_933f695e-e4f4-4c75-80fc-aea9a30aa13d",
  "productndc": "27241-125",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210054",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "May 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "May 28, 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": "ANDA210054",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20190823",
  "active_numerator_strength": "500"
}

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