Lovastatin

Orange BookUNIISPLATC C10AA02

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC10AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4306398330
30 TABLET in 1 BOTTLE, PLASTIC (43063-983-30)

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": "43063-983_303a95e4-2598-7d25-e063-6294a90a5d2a",
  "productndc": "43063-983",
  "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": "20"
}

Related drugs

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