ATORVASTATIN CALCIUM

Orange BookUNIISPLATC C10AA

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC10AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5009064400
30 TABLET, FILM COATED in 1 BOTTLE (50090-6440-0)
ndc11
5009064401
90 TABLET, FILM COATED in 1 BOTTLE (50090-6440-1)
ndc11
5009064402
100 TABLET, FILM COATED in 1 BOTTLE (50090-6440-2)

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": "50090-6440_ca11c467-1901-4879-9e30-90c916fe56af",
  "productndc": "50090-6440",
  "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": "20210801",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code C10AA.

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