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United States · US · US:71335-2697_91732291-fffd-4ec7-820a-917b898d2caf

Atorvastatin calcium

Orange BookUNIISPLATC C10AA05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133526971
    30 TABLET in 1 BOTTLE (71335-2697-1)
  • ndc11
    7133526972
    100 TABLET in 1 BOTTLE (71335-2697-2)
  • ndc11
    7133526973
    90 TABLET in 1 BOTTLE (71335-2697-3)
  • ndc11
    7133526974
    60 TABLET in 1 BOTTLE (71335-2697-4)
  • ndc11
    7133526975
    180 TABLET in 1 BOTTLE (71335-2697-5)
  • ndc11
    7133526976
    10 TABLET in 1 BOTTLE (71335-2697-6)
  • ndc11
    7133526977
    7 TABLET in 1 BOTTLE (71335-2697-7)
  • ndc11
    7133526978
    20 TABLET in 1 BOTTLE (71335-2697-8)

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": "71335-2697_91732291-fffd-4ec7-820a-917b898d2caf",
  "productndc": "71335-2697",
  "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": "40"
}

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