fluvastatin sodium

Generic: fluvastatin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluvastatin sodium
Generic Name fluvastatin
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluvastatin sodium 40 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8021
Product ID 0378-8021_f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090595
Listing Expiration 2027-12-31
Marketing Start 2012-04-11

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 03788021
Hyphenated Format 0378-8021

Supplemental Identifiers

RxCUI
310404 310405
UPC
0303788021930 0303788020933
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 (source: ndc)
Application Number ANDA090595 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93)
source: ndc

Packages (2)

0378-8021-77 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77) 0378-8021-93 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93)

Ingredients (1)

fluvastatin sodium (40 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": "f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9", "openfda": {"upc": ["0303788021930", "0303788020933"], "unii": ["PYF7O1FV7F"], "rxcui": ["310404", "310405"], "spl_set_id": ["d0a7247c-5d83-4bc1-840f-c58314d14195"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-77)", "package_ndc": "0378-8021-77", "marketing_start_date": "20120411"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (0378-8021-93)", "package_ndc": "0378-8021-93", "marketing_start_date": "20120411"}], "brand_name": "Fluvastatin Sodium", "product_id": "0378-8021_f31c30b0-95b9-47d4-8ef8-f6fa51a2e5b9", "dosage_form": "CAPSULE", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0378-8021", "generic_name": "fluvastatin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluvastatin Sodium", "active_ingredients": [{"name": "FLUVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA090595", "marketing_category": "ANDA", "marketing_start_date": "20120411", "listing_expiration_date": "20271231"}