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
7133523931
30 TABLET in 1 BOTTLE (71335-2393-1)
ndc11
7133523932
60 TABLET in 1 BOTTLE (71335-2393-2)
ndc11
7133523933
90 TABLET in 1 BOTTLE (71335-2393-3)
ndc11
7133523934
9 TABLET in 1 BOTTLE (71335-2393-4)
ndc11
7133523935
28 TABLET in 1 BOTTLE (71335-2393-5)
ndc11
7133523936
20 TABLET in 1 BOTTLE (71335-2393-6)
ndc11
7133523937
180 TABLET in 1 BOTTLE (71335-2393-7)
ndc11
7133523938
100 TABLET in 1 BOTTLE (71335-2393-8)
ndc11
7133523939
7 TABLET in 1 BOTTLE (71335-2393-9)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A214659

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": "71335-2393_d8d1f748-70a7-4ded-87ec-a2ef602cd5e6",
  "productndc": "71335-2393",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Jul 14, 2021"
      }
    ],
    "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": "ANDA214659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20220829",
  "active_numerator_strength": "20"
}

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