fluvastatin sodium

Generic: fluvastatin sodium

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvastatin sodium
Generic Name fluvastatin sodium
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

fluvastatin sodium 80 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7446
Product ID 0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079011
Listing Expiration 2026-12-31
Marketing Start 2016-06-02

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 00937446
Hyphenated Format 0093-7446

Supplemental Identifiers

RxCUI
360507
UPC
0300937446019
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 fluvastatin sodium (source: ndc)
Generic Name fluvastatin sodium (source: ndc)
Application Number ANDA079011 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)
source: ndc

Packages (2)

0093-7446-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01) 0093-7446-56 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)

Ingredients (1)

fluvastatin sodium (80 mg/1)

Linked Drug Pages (1)

Fluvastatin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "82469f87-7755-4dda-a92d-a27856d0fe0e", "openfda": {"upc": ["0300937446019"], "unii": ["PYF7O1FV7F"], "rxcui": ["360507"], "spl_set_id": ["cc55110f-1ad6-4f97-840d-62b3a5ac415a"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-01)", "package_ndc": "0093-7446-01", "marketing_start_date": "20160602"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-7446-56)", "package_ndc": "0093-7446-56", "marketing_start_date": "20160602"}], "brand_name": "Fluvastatin Sodium", "product_id": "0093-7446_82469f87-7755-4dda-a92d-a27856d0fe0e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0093-7446", "generic_name": "Fluvastatin Sodium", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvastatin Sodium", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "ANDA079011", "marketing_category": "ANDA", "marketing_start_date": "20160602", "listing_expiration_date": "20261231"}