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United States · US · US:63187-765_045f5277-63a9-43c3-ae26-126a3ad3c16e

Lovastatin

Orange BookUNIISPLATC C10AA02

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC10AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6318776530
    30 TABLET in 1 BOTTLE (63187-765-30)
  • ndc11
    6318776560
    60 TABLET in 1 BOTTLE (63187-765-60)
  • ndc11
    6318776590
    90 TABLET in 1 BOTTLE (63187-765-90)

Annotations

UNII (FDA Substance ID)
9LHU78OQFD
LOVASTATIN
RxCUI 6472
Orange Book
A078296
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": "63187-765_045f5277-63a9-43c3-ae26-126a3ad3c16e",
  "productndc": "63187-765",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078296",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 14, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 1, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Nov 1, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOVASTATIN",
  "proprietary_name": "Lovastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lovastatin",
  "start_marketing_date": "20071101",
  "active_numerator_strength": "20"
}

Related drugs

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