Rosuvastatin

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerScieGen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5022811905
500 TABLET, FILM COATED in 1 BOTTLE (50228-119-05)
ndc11
5022811910
1000 TABLET, FILM COATED in 1 BOTTLE (50228-119-10)
ndc11
5022811930
30 TABLET, FILM COATED in 1 BOTTLE (50228-119-30)
ndc11
5022811990
90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90)

Annotations

UNII (FDA Substance ID)

413KH5ZJ73

ROSUVASTATIN

RxCUI 301542

Orange Book

A206381

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "413KH5ZJ73",
    "rxcui": "301542",
    "inchikey": "BPRHUIZQVSMCRT-VEUZHWNKSA-N",
    "display_name": "ROSUVASTATIN",
    "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": "50228-119_2fb0db87-33a8-e6a1-e063-6294a90a5b4a",
  "productndc": "50228-119",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206381",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 24, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Apr 24, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Apr 24, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Apr 24, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROSUVASTATIN",
  "proprietary_name": "Rosuvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206381",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin",
  "start_marketing_date": "20190424",
  "active_numerator_strength": "40"
}

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