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
7133510101
30 TABLET, FILM COATED in 1 BOTTLE (71335-1010-1)
ndc11
7133510102
60 TABLET, FILM COATED in 1 BOTTLE (71335-1010-2)
ndc11
7133510103
90 TABLET, FILM COATED in 1 BOTTLE (71335-1010-3)
ndc11
7133510104
9 TABLET, FILM COATED in 1 BOTTLE (71335-1010-4)
ndc11
7133510105
28 TABLET, FILM COATED in 1 BOTTLE (71335-1010-5)
ndc11
7133510106
20 TABLET, FILM COATED in 1 BOTTLE (71335-1010-6)
ndc11
7133510107
180 TABLET, FILM COATED in 1 BOTTLE (71335-1010-7)
ndc11
7133510108
100 TABLET, FILM COATED in 1 BOTTLE (71335-1010-8)
ndc11
7133510109
7 TABLET, FILM COATED in 1 BOTTLE (71335-1010-9)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A076477

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": "71335-1010_b74ba5ea-e623-4044-a17e-e16428125e73",
  "productndc": "71335-1010",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076477",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Nov 30, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Nov 30, 2011"
      }
    ],
    "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": "ANDA076477",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20111201",
  "active_numerator_strength": "20"
}

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