Atorvastatin calcium

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerNIVAGEN PHARMACEUTICALS, INC.

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7583425601
1000 TABLET in 1 BOTTLE (75834-256-01)
ndc11
7583425605
5000 TABLET in 1 BOTTLE (75834-256-05)
ndc11
7583425650
500 TABLET in 1 BOTTLE (75834-256-50)
ndc11
7583425690
90 TABLET in 1 BOTTLE (75834-256-90)

Annotations

UNII (FDA Substance ID)

A0JWA85V8F

ATORVASTATIN

RxCUI 83367

Orange Book

A213853

BXBXBXBX

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "A0JWA85V8F",
    "rxcui": "83367",
    "inchikey": "XUKUURHRXDUEBC-KAYWLYCHSA-N",
    "display_name": "ATORVASTATIN",
    "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": "75834-256_4580fe3c-b524-3a14-e063-6294a90a34d3",
  "productndc": "75834-256",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213853",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Aug 19, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Aug 19, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN",
  "proprietary_name": "Atorvastatin calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin calcium",
  "start_marketing_date": "20200826",
  "active_numerator_strength": "20"
}

Related drugs

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