Simvastatin

Orange BookUNIISPLATC C10AA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC10AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133518911
30 TABLET, FILM COATED in 1 BOTTLE (71335-1891-1)
ndc11
7133518912
60 TABLET, FILM COATED in 1 BOTTLE (71335-1891-2)
ndc11
7133518913
100 TABLET, FILM COATED in 1 BOTTLE (71335-1891-3)
ndc11
7133518914
90 TABLET, FILM COATED in 1 BOTTLE (71335-1891-4)
ndc11
7133518915
120 TABLET, FILM COATED in 1 BOTTLE (71335-1891-5)
ndc11
7133518916
180 TABLET, FILM COATED in 1 BOTTLE (71335-1891-6)
ndc11
7133518917
3 TABLET, FILM COATED in 1 BOTTLE (71335-1891-7)
ndc11
7133518918
10 TABLET, FILM COATED in 1 BOTTLE (71335-1891-8)

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": "71335-1891_b410c937-f9a1-4089-8ede-265c2dbc32d4",
  "productndc": "71335-1891",
  "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": "20"
}

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