Crestor

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerAstraZeneca Pharmaceuticals LP

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0310758090
90 TABLET, FILM COATED in 1 BOTTLE (0310-7580-90)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

N021366

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "83MVU38M7Q",
    "rxcui": "323828",
    "inchikey": "LALFOYNTGMUKGG-BGRFNVSISA-L",
    "display_name": "ROSUVASTATIN CALCIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "325a5d0e-9a72-4015-9fcd-1655fb504cee": {
      "match": "brand_token",
      "title": "CRESTOR (ROSUVASTATIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "14",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0310-7580_afc9b415-ee6f-4905-a281-13e74dcf6ce6",
  "productndc": "0310-7580",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021366",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "002",
        "approval_date": "Aug 12, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "003",
        "approval_date": "Aug 12, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Aug 12, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "005",
        "approval_date": "Aug 12, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROSUVASTATIN CALCIUM",
  "proprietary_name": "Crestor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021366",
  "marketing_category": "NDA",
  "nonproprietary_name": "Rosuvastatin",
  "start_marketing_date": "20220124",
  "active_numerator_strength": "20"
}

Related drugs

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