ASPRUZYO SPRINKLE

Orange BookUNIISPLATC C01EB18

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

Identification

ManufacturerSUN PHARMACEUTICAL INDUSTRIES, INC.

CountryUS (United States)

ATC codeC01EB18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4733562511
1 GRANULE in 1 PACKET (47335-625-11)
ndc11
4733562530
30 GRANULE in 1 CARTON (47335-625-30)
ndc11
4733562560
60 GRANULE in 1 CARTON (47335-625-60)

Annotations

UNII (FDA Substance ID)

A6IEZ5M406

RANOLAZINE

RxCUI 35829

Orange Book

N216018

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": {
    "dd9f81e4-50da-4551-aed5-559d304df42e": {
      "match": "brand_token",
      "title": "ASPRUZYO SPRINKLE (RANOLAZINE) GRANULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "3",
      "published_date": "2025-01-30"
    }
  },
  "productid": "47335-625_2cd273e4-313f-3562-e063-6394a90ac135",
  "productndc": "47335-625",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "216018",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Feb 28, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RANOLAZINE",
  "proprietary_name": "ASPRUZYO SPRINKLE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA216018",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ranolazine",
  "start_marketing_date": "20220228",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code C01EB18.

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