Rosuvastatin Calcium

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6878883842
20 TABLET, FILM COATED in 1 BOTTLE (68788-8384-2)
ndc11
6878883843
30 TABLET, FILM COATED in 1 BOTTLE (68788-8384-3)
ndc11
6878883846
60 TABLET, FILM COATED in 1 BOTTLE (68788-8384-6)
ndc11
6878883849
90 TABLET, FILM COATED in 1 BOTTLE (68788-8384-9)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

A208898

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": "68788-8384_c272aab8-c834-43bd-a501-3ffd1fa6296a",
  "productndc": "68788-8384",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208898",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Nov 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Nov 22, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Nov 22, 2017"
      }
    ],
    "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": "ANDA208898",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin Calcium",
  "start_marketing_date": "20230301",
  "active_numerator_strength": "10"
}

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