Rosuvastatin Calcium

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerUmedica Laboratories USA Inc.

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6029004501
30 TABLET in 1 BOTTLE (60290-045-01)
ndc11
6029004502
90 TABLET in 1 BOTTLE (60290-045-02)
ndc11
6029004503
500 TABLET in 1 BOTTLE (60290-045-03)
ndc11
6029004504
100 TABLET in 1 BLISTER PACK (60290-045-04)
ndc11
6029004505
1000 TABLET in 1 BOTTLE (60290-045-05)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

A207626

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": {
    "67da041b-7ad5-4309-86b3-8c30a5f9465e": {
      "match": "brand_token",
      "title": "ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "60290-045_4b2de301-734e-64eb-e063-6394a90a5b91",
  "productndc": "60290-045",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207626",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 9, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Apr 9, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Apr 9, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Apr 9, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROSUVASTATIN CALCIUM",
  "proprietary_name": "Rosuvastatin Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207626",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin Calcium",
  "start_marketing_date": "20251130",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C10AA07.

Access this data programmatically

Query Rosuvastatin Calcium 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.

Get a free API key Read the API docs