Simvastatin

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4257104005
500 TABLET in 1 BOTTLE (42571-040-05)
ndc11
4257104010
1000 TABLET in 1 BOTTLE (42571-040-10)
ndc11
4257104030
30 TABLET in 1 BOTTLE (42571-040-30)
ndc11
4257104060
60 TABLET in 1 BOTTLE (42571-040-60)
ndc11
4257104090
90 TABLET in 1 BOTTLE (42571-040-90)

Annotations

UNII (FDA Substance ID)

AGG2FN16EV

SIMVASTATIN

RxCUI 36567

Orange Book

A090383

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": "42571-040_0369d423-9ef2-0191-e063-6294a90a55e7",
  "productndc": "42571-040",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090383",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Sep 16, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Sep 16, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIMVASTATIN",
  "proprietary_name": "Simvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090383",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Simvastatin",
  "start_marketing_date": "20130613",
  "active_numerator_strength": "40"
}

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