Simvastatin

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerXLCare Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7286530901
100 TABLET, FILM COATED in 1 BOTTLE (72865-309-01)
ndc11
7286530905
500 TABLET, FILM COATED in 1 BOTTLE (72865-309-05)
ndc11
7286530910
1000 TABLET, FILM COATED in 1 BOTTLE (72865-309-10)
ndc11
7286530930
30 TABLET, FILM COATED in 1 BOTTLE (72865-309-30)
ndc11
7286530945
45 TABLET, FILM COATED in 1 BOTTLE (72865-309-45)
ndc11
7286530990
90 TABLET, FILM COATED in 1 BOTTLE (72865-309-90)

Annotations

UNII (FDA Substance ID)

AGG2FN16EV

SIMVASTATIN

RxCUI 36567

Orange Book

A200895

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": "72865-309_48bd010d-6429-906e-e063-6394a90ae8b7",
  "productndc": "72865-309",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "200895",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 25, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Nov 25, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "003",
        "approval_date": "Nov 25, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "004",
        "approval_date": "Nov 25, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Nov 25, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SIMVASTATIN",
  "proprietary_name": "Simvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA200895",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Simvastatin",
  "start_marketing_date": "20260121",
  "active_numerator_strength": "80"
}

Related drugs

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