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United States · US · US:71335-2404_af1b3de0-9c50-407d-a154-afd07d4cd731

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 · 9

  • ndc11
    7133524041
    30 TABLET in 1 BOTTLE (71335-2404-1)
  • ndc11
    7133524042
    60 TABLET in 1 BOTTLE (71335-2404-2)
  • ndc11
    7133524043
    90 TABLET in 1 BOTTLE (71335-2404-3)
  • ndc11
    7133524044
    9 TABLET in 1 BOTTLE (71335-2404-4)
  • ndc11
    7133524045
    28 TABLET in 1 BOTTLE (71335-2404-5)
  • ndc11
    7133524046
    20 TABLET in 1 BOTTLE (71335-2404-6)
  • ndc11
    7133524047
    180 TABLET in 1 BOTTLE (71335-2404-7)
  • ndc11
    7133524048
    100 TABLET in 1 BOTTLE (71335-2404-8)
  • ndc11
    7133524049
    7 TABLET in 1 BOTTLE (71335-2404-9)

Annotations

UNII (FDA Substance ID)
48A5M73Z4Q
ATORVASTATIN CALCIUM TRIHYDRATE
RxCUI 1297766
Orange Book
A209912
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": "71335-2404_af1b3de0-9c50-407d-a154-afd07d4cd731",
  "productndc": "71335-2404",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jun 18, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jun 18, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jun 18, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Jun 18, 2018"
      }
    ],
    "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": "ANDA209912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "atorvastatin calcium, film coated",
  "start_marketing_date": "20231020",
  "active_numerator_strength": "20"
}

Related drugs

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