Atorvastatin Calcium

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerCadila Pharmaceuticals Limited

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7120909004
90 TABLET, COATED in 1 BOTTLE (71209-090-04)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A212103

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": {
    "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": "71209-090_547579c7-a528-413f-b402-00f598775df3",
  "productndc": "71209-090",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "212103",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Oct 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Oct 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Oct 16, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Oct 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
  "proprietary_name": "Atorvastatin Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212103",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20180706",
  "active_numerator_strength": "10"
}

Related drugs

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