fluvastatin

Generic: fluvastatin

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

Drug Facts

Product Profile

Brand Name fluvastatin
Generic Name fluvastatin
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluvastatin sodium 40 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7443
Product ID 0093-7443_1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078407
Listing Expiration 2026-12-31
Marketing Start 2012-07-05

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 00937443
Hyphenated Format 0093-7443

Supplemental Identifiers

RxCUI
310404 310405
UPC
0300937443568 0300937442561
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 (source: ndc)
Generic Name fluvastatin (source: ndc)
Application Number ANDA078407 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0093-7443-01)
  • 30 CAPSULE in 1 BOTTLE (0093-7443-56)
source: ndc

Packages (2)

0093-7443-01 100 CAPSULE in 1 BOTTLE (0093-7443-01) 0093-7443-56 30 CAPSULE in 1 BOTTLE (0093-7443-56)

Ingredients (1)

fluvastatin sodium (40 mg/1)

Linked Drug Pages (1)

Fluvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc", "openfda": {"upc": ["0300937443568", "0300937442561"], "unii": ["PYF7O1FV7F"], "rxcui": ["310404", "310405"], "spl_set_id": ["aad8b373-0aec-4efb-8e61-3d8114b31127"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0093-7443-01)", "package_ndc": "0093-7443-01", "marketing_start_date": "20120710"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0093-7443-56)", "package_ndc": "0093-7443-56", "marketing_start_date": "20120705"}], "brand_name": "Fluvastatin", "product_id": "0093-7443_1fb50b66-e9d0-4fd1-928e-b37c4fff4ccc", "dosage_form": "CAPSULE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0093-7443", "generic_name": "Fluvastatin", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvastatin", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA078407", "marketing_category": "ANDA", "marketing_start_date": "20120705", "listing_expiration_date": "20261231"}