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United States · US · US:29300-296_429d55c7-1e90-4345-a6d4-59f689557f40

Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeC01EB18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2930029601
    100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-01)
  • ndc11
    2930029605
    500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-05)
  • ndc11
    2930029616
    60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-296-16)

Annotations

UNII (FDA Substance ID)
A6IEZ5M406
RANOLAZINE
RxCUI 35829
Orange Book
A213083
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": "29300-296_429d55c7-1e90-4345-a6d4-59f689557f40",
  "productndc": "29300-296",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "213083",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Mar 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANOLAZINE",
  "proprietary_name": "Ranolazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213083",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20230316",
  "active_numerator_strength": "500"
}

Related drugs

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