Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6330401805
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-05)
ndc11
6330401828
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-28)
ndc11
6330401860
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63304-018-60)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

A211707

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": "63304-018_9d320810-99dc-4276-ab06-688b60cc957d",
  "productndc": "63304-018",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211707",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "May 28, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "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": "ANDA211707",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20190528",
  "active_numerator_strength": "1000"
}

Related drugs

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