fluvastatin

Generic: fluvastatin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvastatin
Generic Name fluvastatin
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluvastatin sodium 20 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8812
Product ID 63629-8812_a94b896f-6170-4ada-970d-9e1e130c7eab
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 636298812
Hyphenated Format 63629-8812

Supplemental Identifiers

RxCUI
310404
UNII
PYF7O1FV7F

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
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63629-8812-1)
source: ndc

Packages (1)

63629-8812-1 100 CAPSULE in 1 BOTTLE (63629-8812-1)

Ingredients (1)

fluvastatin sodium (20 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": "a94b896f-6170-4ada-970d-9e1e130c7eab", "openfda": {"unii": ["PYF7O1FV7F"], "rxcui": ["310404"], "spl_set_id": ["f5e8d1da-8911-42db-9f90-cba04b28d011"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63629-8812-1)", "package_ndc": "63629-8812-1", "marketing_start_date": "20210910"}], "brand_name": "Fluvastatin", "product_id": "63629-8812_a94b896f-6170-4ada-970d-9e1e130c7eab", "dosage_form": "CAPSULE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "63629-8812", "generic_name": "Fluvastatin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvastatin", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA078407", "marketing_category": "ANDA", "marketing_start_date": "20120705", "listing_expiration_date": "20261231"}