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United States · US · US:66758-211_726ea2db-f1b0-4b73-a515-02157db88a42
Lescol
In shortageOrange BookUNIISPLATC C10AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeC10AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11667582113130 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)
Annotations
UNII (FDA Substance ID)
PYF7O1FV7F
FLUVASTATIN SODIUM
RxCUI 72875
Orange Book
N021192
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": {
"726ea2db-f1b0-4b73-a515-02157db88a42": {
"match": "brand_token",
"title": "LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]",
"spl_version": "1",
"published_date": "2024-08-05"
}
},
"productid": "66758-211_726ea2db-f1b0-4b73-a515-02157db88a42",
"productndc": "66758-211",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021192",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 80MG BASE",
"product_no": "001",
"approval_date": "Oct 6, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FLUVASTATIN SODIUM",
"shortage_reason": "Fluvastatin Sodium Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Lescol",
"active_ingred_unit": "mg/1",
"application_number": "NDA021192",
"marketing_category": "NDA",
"nonproprietary_name": "fluvastatin sodium",
"start_marketing_date": "20001006",
"active_numerator_strength": "80"
}Related drugs
Other records sharing ATC code C10AA04.
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