Simvastatin

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
6586205000
100 TABLET, FILM COATED in 1 BOTTLE (65862-050-00)
ndc11
6586205001
100 TABLET, FILM COATED in 1 BOTTLE (65862-050-01)
ndc11
6586205026
2500 TABLET, FILM COATED in 1 BOTTLE (65862-050-26)
ndc11
6586205030
30 TABLET, FILM COATED in 1 BOTTLE (65862-050-30)
ndc11
6586205045
45 TABLET, FILM COATED in 1 BOTTLE (65862-050-45)
ndc11
6586205090
90 TABLET, FILM COATED in 1 BOTTLE (65862-050-90)
ndc11
6586205099
1000 TABLET, FILM COATED in 1 BOTTLE (65862-050-99)

Annotations

UNII (FDA Substance ID)

AGG2FN16EV

SIMVASTATIN

RxCUI 36567

Orange Book

A077691

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": "65862-050_854ac8f7-cca5-434c-a611-9c1752260d4a",
  "productndc": "65862-050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077691",
    "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": "ANDA077691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Simvastatin",
  "start_marketing_date": "20061220",
  "active_numerator_strength": "5"
}

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