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United States · US · US:0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e
Fluvastatin Sodium
In shortageOrange BookUNIISPLATC C10AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeC10AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110093744601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)
- ndc11009374465630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)
Annotations
UNII (FDA Substance ID)
PYF7O1FV7F
FLUVASTATIN SODIUM
RxCUI 72875
Orange Book
A079011
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": "0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e",
"productndc": "0093-7446",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079011",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 80MG BASE",
"product_no": "001",
"approval_date": "Jan 27, 2016"
}
],
"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": "ANDA079011",
"marketing_category": "ANDA",
"nonproprietary_name": "Fluvastatin Sodium",
"start_marketing_date": "20160602",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C10AA04.
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