Fluvastatin Sodium

In shortageOrange BookUNIISPLATC C10AA04

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC10AA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0378802077
90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-77)
ndc11
0378802093
30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8020-93)

Annotations

UNII (FDA Substance ID)

PYF7O1FV7F

FLUVASTATIN SODIUM

RxCUI 72875

Orange Book

A090595

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": "0378-8020_f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9",
  "productndc": "0378-8020",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090595",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Apr 11, 2012"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Apr 11, 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 Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090595",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fluvastatin",
  "start_marketing_date": "20120411",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C10AA04.

Access this data programmatically

Query Fluvastatin Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs