Ranolazine

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4257132511
100 BLISTER PACK in 1 CARTON (42571-325-11) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (42571-325-32)
ndc11
4257132560
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-325-60)
ndc11
4257132564
180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-325-64)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

A211745

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": "42571-325_d172a3c8-ae0a-9ccb-e053-2a95a90a069e",
  "productndc": "42571-325",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211745",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Feb 27, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Feb 27, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANOLAZINE",
  "proprietary_name": "Ranolazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211745",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20200601",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code C01EB18.

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