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United States · US · US:50090-0757_80023785-4b99-48c1-b757-c391056fe6fc

Lovastatin

Orange BookUNIISPLATC C10AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC10AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009007570
    30 TABLET in 1 BOTTLE (50090-0757-0)
  • ndc11
    5009007571
    90 TABLET in 1 BOTTLE (50090-0757-1)

Annotations

UNII (FDA Substance ID)
9LHU78OQFD
LOVASTATIN
RxCUI 6472
Orange Book
A075991
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9LHU78OQFD",
    "rxcui": "6472",
    "inchikey": "PCZOHLXUXFIOCF-BXMDZJJMSA-N",
    "display_name": "LOVASTATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f5f265a6-2aa5-4205-9159-40133ae93ac0": {
      "match": "brand_token",
      "title": "LOVASTATIN TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50090-0757_80023785-4b99-48c1-b757-c391056fe6fc",
  "productndc": "50090-0757",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075991",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jun 5, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jun 5, 2002"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Jun 5, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOVASTATIN",
  "proprietary_name": "Lovastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075991",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lovastatin",
  "start_marketing_date": "20021125",
  "active_numerator_strength": "10"
}

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