Fluvastatin

In shortageOrange BookUNIISPLATC C10AA04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeC10AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362988121
100 CAPSULE in 1 BOTTLE (63629-8812-1)

Annotations

UNII (FDA Substance ID)

PYF7O1FV7F

FLUVASTATIN SODIUM

RxCUI 72875

Orange Book

A078407

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Fluvastatin Sodium Tablet, Extended Release

Raw payload (JSON)

{
  "unii": {
    "unii": "PYF7O1FV7F",
    "rxcui": "72875",
    "inchikey": "ZGGHKIMDNBDHJB-RPQBTBOMSA-M;ZGGHKIMDNBDHJB-NRFPMOEYSA-M",
    "display_name": "FLUVASTATIN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ccd6bbe1-e293-4e1c-9ec4-e6c217612e77": {
      "match": "brand_token",
      "title": "FLUVASTATIN CAPSULE [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-04-13"
    }
  },
  "productid": "63629-8812_a94b896f-6170-4ada-970d-9e1e130c7eab",
  "productndc": "63629-8812",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 12, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jun 12, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUVASTATIN SODIUM",
  "shortage_reason": "Fluvastatin Sodium Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Fluvastatin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluvastatin",
  "start_marketing_date": "20120705",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C10AA04.

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