Lipitor

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5815115777
90 TABLET, FILM COATED in 1 BOTTLE (58151-157-77)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

N020702

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "48A5M73Z4Q",
    "rxcui": "1297766",
    "inchikey": "SHZPNDRIDUBNMH-NIJVSVLQSA-L",
    "display_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a60cc18b-0631-4cf0-b021-9f52224ece65": {
      "match": "brand_token",
      "title": "LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]",
      "spl_version": "7",
      "published_date": "2024-06-27"
    }
  },
  "productid": "58151-157_e0f7e582-ef7c-4498-9871-55e4f48345ad",
  "productndc": "58151-157",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020702",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Dec 17, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Dec 17, 1996"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Dec 17, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Apr 7, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
  "proprietary_name": "Lipitor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020702",
  "marketing_category": "NDA",
  "nonproprietary_name": "atorvastatin calcium",
  "start_marketing_date": "20240103",
  "active_numerator_strength": "40"
}

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