ATORVASTATIN CALCIUM

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4257117210
1000 TABLET, FILM COATED in 1 BOTTLE (42571-172-10)
ndc11
4257117211
10 BLISTER PACK in 1 CARTON (42571-172-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-172-32)
ndc11
4257117230
30 TABLET, FILM COATED in 1 BOTTLE (42571-172-30)
ndc11
4257117290
90 TABLET, FILM COATED in 1 BOTTLE (42571-172-90)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A205945

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": {
    "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": "42571-172_336c8e4f-ccef-2741-e063-6294a90a4520",
  "productndc": "42571-172",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205945",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Nov 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Nov 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Nov 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Nov 7, 2019"
      }
    ],
    "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": "ANDA205945",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ATORVASTATIN CALCIUM",
  "start_marketing_date": "20200101",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AA05.

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