ATORVASTATIN CALCIUM

Orange BookUNIISPLATC C10AA

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC10AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7133510511
30 TABLET, FILM COATED in 1 BOTTLE (71335-1051-1)
ndc11
7133510512
60 TABLET, FILM COATED in 1 BOTTLE (71335-1051-2)
ndc11
7133510513
90 TABLET, FILM COATED in 1 BOTTLE (71335-1051-3)
ndc11
7133510514
9 TABLET, FILM COATED in 1 BOTTLE (71335-1051-4)
ndc11
7133510515
28 TABLET, FILM COATED in 1 BOTTLE (71335-1051-5)
ndc11
7133510516
20 TABLET, FILM COATED in 1 BOTTLE (71335-1051-6)
ndc11
7133510517
180 TABLET, FILM COATED in 1 BOTTLE (71335-1051-7)
ndc11
7133510518
100 TABLET, FILM COATED in 1 BOTTLE (71335-1051-8)
ndc11
7133510519
7 TABLET, FILM COATED in 1 BOTTLE (71335-1051-9)

Annotations

UNII (FDA Substance ID)

YRZ789OWMI

ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

RxCUI 1483793

Orange Book

A090548

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YRZ789OWMI",
    "rxcui": "1483793",
    "inchikey": "KNMXZASRMVGUNA-SVWYKLQNSA-L",
    "display_name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
    "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": "71335-1051_7dd59be7-0b85-434a-925b-e2b9926f9e45",
  "productndc": "71335-1051",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090548",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "May 29, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "May 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE",
  "proprietary_name": "ATORVASTATIN CALCIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090548",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ATORVASTATIN CALCIUM",
  "start_marketing_date": "20120529",
  "active_numerator_strength": "20"
}

Related drugs

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