Atorvastatin Calcium

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7642094800
1000 TABLET, FILM COATED in 1 BOTTLE (76420-948-00)
ndc11
7642094805
500 TABLET, FILM COATED in 1 BOTTLE (76420-948-05)
ndc11
7642094812
120 TABLET, FILM COATED in 1 BOTTLE (76420-948-12)
ndc11
7642094820
20 TABLET, FILM COATED in 1 BOTTLE (76420-948-20)
ndc11
7642094830
30 TABLET, FILM COATED in 1 BOTTLE (76420-948-30)
ndc11
7642094838
10 BLISTER PACK in 1 CARTON (76420-948-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642094860
60 TABLET, FILM COATED in 1 BOTTLE (76420-948-60)
ndc11
7642094890
90 TABLET, FILM COATED in 1 BOTTLE (76420-948-90)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A209288

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": "76420-948_352ed2e2-c7bd-ae21-e063-6394a90ad835",
  "productndc": "76420-948",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209288",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Dec 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Dec 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Dec 21, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Dec 21, 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": "ANDA209288",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20181223",
  "active_numerator_strength": "80"
}

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