ATORVASTATIN CALCIUM

Orange BookUNIISPLATC C10AA

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeC10AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6050526710
10 BLISTER PACK in 1 CARTON (60505-2671-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6050526713
30 TABLET, FILM COATED in 1 BOTTLE (60505-2671-3)
ndc11
6050526715
500 TABLET, FILM COATED in 1 BOTTLE (60505-2671-5)
ndc11
6050526717
2500 TABLET, FILM COATED in 1 BOTTLE (60505-2671-7)
ndc11
6050526718
1000 TABLET, FILM COATED in 1 BOTTLE (60505-2671-8)
ndc11
6050526719
90 TABLET, FILM COATED in 1 BOTTLE (60505-2671-9)

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": "60505-2671_bd45e325-1a2b-b3da-7fd8-58b7ce2a8483",
  "productndc": "60505-2671",
  "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": "20120529",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code C10AA.

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