Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5965100918
180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-18)
ndc11
5965100960
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-60)
ndc11
5965100999
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-009-99)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

A209081

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": "59651-009_ee3c2383-a36a-4abe-9764-89f817798f28",
  "productndc": "59651-009",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209081",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Dec 23, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANOLAZINE",
  "proprietary_name": "Ranolazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20221223",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code C01EB18.

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