Atorvastatin calcium

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133527991
30 TABLET, FILM COATED in 1 BOTTLE (71335-2799-1)
ndc11
7133527992
60 TABLET, FILM COATED in 1 BOTTLE (71335-2799-2)
ndc11
7133527993
90 TABLET, FILM COATED in 1 BOTTLE (71335-2799-3)
ndc11
7133527994
9 TABLET, FILM COATED in 1 BOTTLE (71335-2799-4)
ndc11
7133527995
28 TABLET, FILM COATED in 1 BOTTLE (71335-2799-5)
ndc11
7133527996
20 TABLET, FILM COATED in 1 BOTTLE (71335-2799-6)
ndc11
7133527997
180 TABLET, FILM COATED in 1 BOTTLE (71335-2799-7)
ndc11
7133527998
100 TABLET, FILM COATED in 1 BOTTLE (71335-2799-8)
ndc11
7133527999
7 TABLET, FILM COATED in 1 BOTTLE (71335-2799-9)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A211933

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": "71335-2799_55560bb6-85b8-4e62-bd68-33ced6dac155",
  "productndc": "71335-2799",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211933",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Feb 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Feb 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Feb 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Feb 8, 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": "ANDA211933",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin calcium",
  "start_marketing_date": "20190208",
  "active_numerator_strength": "20"
}

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