Rosuvastatin

Orange BookUNIISPLATC C10AA07

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

Identification

ManufacturerAiPing Pharmaceutical, Inc.

CountryUS (United States)

ATC codeC10AA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1178813205
500 TABLET, COATED in 1 BOTTLE (11788-132-05)
ndc11
1178813210
1000 TABLET, COATED in 1 BOTTLE (11788-132-10)
ndc11
1178813290
90 TABLET, COATED in 1 BOTTLE (11788-132-90)

Annotations

UNII (FDA Substance ID)

83MVU38M7Q

ROSUVASTATIN CALCIUM

RxCUI 323828

Orange Book

A206513

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": "11788-132_42b21540-4538-4c56-adb7-b9cfe8b2b2d5",
  "productndc": "11788-132",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "206513",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Mar 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Mar 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "004",
        "approval_date": "Mar 1, 2019"
      }
    ],
    "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": "ANDA206513",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rosuvastatin",
  "start_marketing_date": "20260130",
  "active_numerator_strength": "20"
}

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