SIMVASTATIN

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0615799205
15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05)
ndc11
0615799239
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39)

Annotations

UNII (FDA Substance ID)

AGG2FN16EV

SIMVASTATIN

RxCUI 36567

Orange Book

A078103

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "AGG2FN16EV",
    "rxcui": "36567",
    "inchikey": "RYMZZMVNJRMUDD-HGQWONQESA-N",
    "display_name": "SIMVASTATIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52573b98-6e51-9753-e063-6294a90ac8c4": {
      "match": "brand_token",
      "title": "SIMVASTATIN TABLET, FILM COATED [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0615-7992_e25097c4-9328-4625-82f4-724d3057ce30",
  "productndc": "0615-7992",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078103",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 11, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "May 11, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "May 11, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "004",
        "approval_date": "May 11, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Apr 14, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIMVASTATIN",
  "proprietary_name": "SIMVASTATIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078103",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SIMVASTATIN",
  "start_marketing_date": "20070612",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code C10AA01.

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