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United States · US · US:0527-2580_4d56c57e-1d38-e010-e063-6294a90a8c83
Fluvastatin Sodium
In shortageOrange BookUNIISPLATC C10AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeC10AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11052725803230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)
- ndc110527258037100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)
Annotations
UNII (FDA Substance ID)
PYF7O1FV7F
FLUVASTATIN SODIUM
RxCUI 72875
Orange Book
A209397
AB
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": "0527-2580_4d56c57e-1d38-e010-e063-6294a90a8c83",
"productndc": "0527-2580",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209397",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 80MG BASE",
"product_no": "001",
"approval_date": "Apr 26, 2021"
}
],
"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": "ANDA209397",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluvastatin Sodium",
"start_marketing_date": "20210507",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C10AA04.
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