Back to search
🇺🇸

United States · US · US:46287-030_fb92775a-6d6d-4d62-ab23-045f16ec5895

ATORVALIQ

Orange BookUNIISPLATC C10AA05

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

Identification

ManufacturerCMP Pharma, Inc.
CountryUS (United States)
ATC codeC10AA05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4628703001
    150 mL in 1 BOTTLE (46287-030-01)

Annotations

UNII (FDA Substance ID)
48A5M73Z4Q
ATORVASTATIN CALCIUM TRIHYDRATE
RxCUI 1297766
Orange Book
N213260
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": {
    "41fca2d8-7f3f-45b9-8974-81b89accc211": {
      "match": "brand_token",
      "title": "ATORVALIQ SUSPENSION [CMP PHARMA, INC.]",
      "spl_version": "3",
      "published_date": "2024-08-23"
    }
  },
  "productid": "46287-030_fb92775a-6d6d-4d62-ab23-045f16ec5895",
  "productndc": "46287-030",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "213260",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/5ML",
        "product_no": "001",
        "approval_date": "Feb 1, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
  "proprietary_name": "ATORVALIQ",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA213260",
  "marketing_category": "NDA",
  "nonproprietary_name": "ATORVALIQ",
  "start_marketing_date": "20230301",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C10AA05.

Access this data programmatically

Query ATORVALIQ and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.