Atorvastatin Calcium

Orange BookUNIISPLATC C10AA

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

Identification

ManufacturerCardinal Health 107, LLC

CountryUS (United States)

ATC codeC10AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515466340
10 BLISTER PACK in 1 BAG (55154-6634-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

YRZ789OWMI

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

RxCUI 1483793

Orange Book

A090548

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YRZ789OWMI",
    "rxcui": "1483793",
    "inchikey": "KNMXZASRMVGUNA-SVWYKLQNSA-L",
    "display_name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52f99e39-fb92-e9f5-e063-6294a90a1b6a": {
      "match": "brand_token",
      "title": "ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "55154-6634_8922e6cc-453f-4271-91da-e93803b0ab43",
  "productndc": "55154-6634",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090548",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "May 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
  "proprietary_name": "Atorvastatin Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090548",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20130709",
  "active_numerator_strength": "20"
}

Related drugs

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