Rosuvastatin

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
7133524981
30 TABLET, FILM COATED in 1 BOTTLE (71335-2498-1)
ndc11
7133524982
90 TABLET, FILM COATED in 1 BOTTLE (71335-2498-2)
ndc11
7133524983
28 TABLET, FILM COATED in 1 BOTTLE (71335-2498-3)
ndc11
7133524984
10 TABLET, FILM COATED in 1 BOTTLE (71335-2498-4)
ndc11
7133524985
60 TABLET, FILM COATED in 1 BOTTLE (71335-2498-5)

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": "71335-2498_029a4920-fc8c-466d-a283-2ec641d445ce",
  "productndc": "71335-2498",
  "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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