Simvastatin

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009064590
30 TABLET, FILM COATED in 1 BOTTLE (50090-6459-0)

Annotations

UNII (FDA Substance ID)

AGG2FN16EV

SIMVASTATIN

RxCUI 36567

Orange Book

A078034

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": "50090-6459_a6bec4e9-7e8c-42b5-861b-4bf87b934118",
  "productndc": "50090-6459",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078034",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Dec 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Dec 20, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Dec 20, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIMVASTATIN",
  "proprietary_name": "Simvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078034",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Simvastatin",
  "start_marketing_date": "20151217",
  "active_numerator_strength": "5"
}

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