RANOLAZINE

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerRadha Pharmaceuticals, Inc

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7777142360
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (77771-423-60)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

A211829

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": "77771-423_2db3da6f-14f6-4c55-ad22-55e475ad9f09",
  "productndc": "77771-423",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jun 4, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Jun 4, 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": "ANDA211829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RANOLAZINE",
  "start_marketing_date": "20250630",
  "active_numerator_strength": "500"
}

Related drugs

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