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United States · US · US:71205-868_278d3fa3-3304-43dc-8a2a-a463c8ae9e9d

Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC01EB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7120586800
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-00)
  • ndc11
    7120586830
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-30)
  • ndc11
    7120586855
    500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-55)
  • ndc11
    7120586860
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-60)
  • ndc11
    7120586872
    120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-72)
  • ndc11
    7120586878
    180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-78)
  • ndc11
    7120586890
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-90)

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": "71205-868_278d3fa3-3304-43dc-8a2a-a463c8ae9e9d",
  "productndc": "71205-868",
  "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": "20210824",
  "active_numerator_strength": "1000"
}

Related drugs

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