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United States · US · US:60687-549_23955366-9210-f95f-e063-6394a90a7e99

Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeC01EB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068754921
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-549-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-549-11)

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": "60687-549_23955366-9210-f95f-e063-6394a90a7e99",
  "productndc": "60687-549",
  "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": "20200819",
  "active_numerator_strength": "500"
}

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