fluvastatin sodium

Generic: fluvastatin sodium

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fluvastatin sodium 80 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-2580
Product ID 0527-2580_4833f7ac-8026-1db1-e063-6394a90a3a86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209397
Listing Expiration 2027-12-31
Marketing Start 2021-05-07

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 05272580
Hyphenated Format 0527-2580

Supplemental Identifiers

RxCUI
360507
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 ANDA209397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)
source: ndc

Packages (2)

0527-2580-32 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32) 0527-2580-37 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)

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": "4833f7ac-8026-1db1-e063-6394a90a3a86", "openfda": {"unii": ["PYF7O1FV7F"], "rxcui": ["360507"], "spl_set_id": ["3565bfd3-ef9f-456d-b4be-a294a7a0f01c"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-32)", "package_ndc": "0527-2580-32", "marketing_start_date": "20210507"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0527-2580-37)", "package_ndc": "0527-2580-37", "marketing_start_date": "20220314"}], "brand_name": "Fluvastatin Sodium", "product_id": "0527-2580_4833f7ac-8026-1db1-e063-6394a90a3a86", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0527-2580", "generic_name": "Fluvastatin Sodium", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvastatin Sodium", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "ANDA209397", "marketing_category": "ANDA", "marketing_start_date": "20210507", "listing_expiration_date": "20271231"}