Lovastatin

Orange BookUNIISPLATC C10AA02

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeC10AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807136221
100 TABLET in 1 BOTTLE (68071-3622-1)

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": "68071-3622_1ac8077a-4db7-2659-e063-6294a90aa043",
  "productndc": "68071-3622",
  "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": "20080314",
  "active_numerator_strength": "10"
}

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