Atorvastatin Calcium

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerLaurus Labs Limited

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4238594201
100 TABLET, FILM COATED in 1 BOTTLE (42385-942-01)
ndc11
4238594205
500 TABLET, FILM COATED in 1 BOTTLE (42385-942-05)
ndc11
4238594211
1000 TABLET, FILM COATED in 1 BOTTLE (42385-942-11)
ndc11
4238594230
30 TABLET, FILM COATED in 1 BOTTLE (42385-942-30)
ndc11
4238594268
10 BLISTER PACK in 1 CARTON (42385-942-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-942-10)
ndc11
4238594290
90 TABLET, FILM COATED in 1 BOTTLE (42385-942-90)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A214513

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": "42385-942_ba8208d7-c3b8-4ddc-8826-9f5265513bfa",
  "productndc": "42385-942",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214513",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jan 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jan 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jan 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Jan 22, 2024"
      }
    ],
    "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": "ANDA214513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20240123",
  "active_numerator_strength": "40"
}

Related drugs

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