Rosuvastatin

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334226207
30 TABLET in 1 CONTAINER (33342-262-07)
ndc11
3334226210
90 TABLET in 1 CONTAINER (33342-262-10)
ndc11
3334226212
10 BLISTER PACK in 1 CARTON (33342-262-12) / 10 TABLET in 1 BLISTER PACK
ndc11
3334226244
1000 TABLET in 1 CONTAINER (33342-262-44)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

A207296

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": "33342-262_d7b9f280-bda6-40d4-9778-e45efb87ab23",
  "productndc": "33342-262",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207296",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 6, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Nov 6, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Nov 6, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Nov 6, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROSUVASTATIN CALCIUM",
  "proprietary_name": "Rosuvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin",
  "start_marketing_date": "20241106",
  "active_numerator_strength": "10"
}

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