ATORVASTATIN CALCIUM

Orange BookUNIISPLATC C10AA

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs

CountryUS (United States)

ATC codeC10AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
0615800705
15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8007-05)
ndc11
0615800707
7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8007-07)
ndc11
0615800714
14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8007-14)
ndc11
0615800728
28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8007-28)
ndc11
0615800730
6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8007-30) / 5 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
0615800739
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8007-39)

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": "0615-8007_77d8e3d2-c909-4c76-9572-f838179cd722",
  "productndc": "0615-8007",
  "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": "20"
}

Related drugs

Other records sharing ATC code C10AA.

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