lescol xl

Generic: fluvastatin sodium

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lescol xl
Generic Name fluvastatin sodium
Labeler sandoz inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fluvastatin sodium 80 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-211
Product ID 66758-211_726ea2db-f1b0-4b73-a515-02157db88a42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021192
Listing Expiration 2026-12-31
Marketing Start 2000-10-06

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758211
Hyphenated Format 66758-211

Supplemental Identifiers

RxCUI
360507 687048
UNII
PYF7O1FV7F

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lescol xl (source: ndc)
Generic Name fluvastatin sodium (source: ndc)
Application Number NDA021192 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)
source: ndc

Packages (1)

66758-211-31 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)

Ingredients (1)

fluvastatin sodium (80 mg/1)

Linked Drug Pages (1)

Lescol XL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "726ea2db-f1b0-4b73-a515-02157db88a42", "openfda": {"unii": ["PYF7O1FV7F"], "rxcui": ["360507", "687048"], "spl_set_id": ["726ea2db-f1b0-4b73-a515-02157db88a42"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31)", "package_ndc": "66758-211-31", "marketing_start_date": "20240802"}], "brand_name": "Lescol XL", "product_id": "66758-211_726ea2db-f1b0-4b73-a515-02157db88a42", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "66758-211", "generic_name": "fluvastatin sodium", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lescol", "brand_name_suffix": "XL", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "NDA021192", "marketing_category": "NDA", "marketing_start_date": "20001006", "listing_expiration_date": "20261231"}