Rosuvastatin calcium

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerGlenmark Pharmaceutials Inc., USA

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6846226301
100 TABLET, FILM COATED in 1 BOTTLE (68462-263-01)
ndc11
6846226310
1000 TABLET, FILM COATED in 1 BOTTLE (68462-263-10)
ndc11
6846226311
10 BLISTER PACK in 1 CARTON (68462-263-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6846226330
30 TABLET, FILM COATED in 1 BOTTLE (68462-263-30)
ndc11
6846226350
50 TABLET, FILM COATED in 1 BOTTLE (68462-263-50)
ndc11
6846226390
90 TABLET, FILM COATED in 1 BOTTLE (68462-263-90)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

A079172

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": "68462-263_958b8936-9395-42e0-8c3b-3247a20621c4",
  "productndc": "68462-263",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079172",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jul 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Jul 19, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Jul 19, 2016"
      }
    ],
    "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": "ANDA079172",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin calcium",
  "start_marketing_date": "20160719",
  "active_numerator_strength": "20"
}

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