fluvastatin sodium er

Generic: fluvastatin sodium

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

Drug Facts

Product Profile

Brand Name fluvastatin sodium er
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 0781-8017
Product ID 0781-8017_37375ca6-3a81-4d10-9b39-9aee948e51a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021192
Listing Expiration 2026-12-31
Marketing Start 2015-10-16

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 07818017
Hyphenated Format 0781-8017

Supplemental Identifiers

RxCUI
360507
UPC
0307818017313
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 er (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
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)
source: ndc

Packages (2)

0781-8017-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01) 0781-8017-31 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)

Ingredients (1)

fluvastatin sodium (80 mg/1)

Linked Drug Pages (1)

FLUVASTATIN SODIUM ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "37375ca6-3a81-4d10-9b39-9aee948e51a4", "openfda": {"upc": ["0307818017313"], "unii": ["PYF7O1FV7F"], "rxcui": ["360507"], "spl_set_id": ["5ab4296c-87c2-4c64-b218-d620eef51310"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-01)", "package_ndc": "0781-8017-01", "marketing_start_date": "20180502"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8017-31)", "package_ndc": "0781-8017-31", "marketing_start_date": "20180502"}], "brand_name": "FLUVASTATIN SODIUM ER", "product_id": "0781-8017_37375ca6-3a81-4d10-9b39-9aee948e51a4", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0781-8017", "generic_name": "fluvastatin sodium", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUVASTATIN SODIUM", "brand_name_suffix": "ER", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "80 mg/1"}], "application_number": "NDA021192", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20151016", "listing_expiration_date": "20261231"}