Ranolazine

Orange BookUNIISPLATC C01EB18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerViona Pharmaceuticals Inc

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7257806401
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-01)
ndc11
7257806405
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-05)
ndc11
7257806414
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-064-14)
ndc11
7257806477
10 BLISTER PACK in 1 CARTON (72578-064-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (72578-064-30)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

A210188

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": "72578-064_ca6a476b-e330-4618-8661-08ac1125fc3e",
  "productndc": "72578-064",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "210188",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Aug 19, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Aug 19, 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": "ANDA210188",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20190910",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code C01EB18.

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