simvastatin

Generic: simvastatin

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 80 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-377
Product ID 69367-377_5bcccfd7-0ae8-4fad-a535-5efa7b327550
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211394
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367377
Hyphenated Format 69367-377

Supplemental Identifiers

RxCUI
198211 200345 312961 314231
UPC
0369367374101 0369367375108 0369367376105
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

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 simvastatin (source: ndc)
Generic Name simvastatin (source: ndc)
Application Number ANDA211394 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (69367-377-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69367-377-10)
source: ndc

Packages (2)

69367-377-09 90 TABLET, FILM COATED in 1 BOTTLE (69367-377-09) 69367-377-10 1000 TABLET, FILM COATED in 1 BOTTLE (69367-377-10)

Ingredients (1)

simvastatin (80 mg/1)

Linked Drug Pages (1)

Simvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5bcccfd7-0ae8-4fad-a535-5efa7b327550", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0369367374101", "0369367375108", "0369367376105"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "314231"], "spl_set_id": ["acaaab63-c9ff-44c9-8fde-9a4ea6454dd7"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69367-377-09)", "package_ndc": "69367-377-09", "marketing_start_date": "20250414"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69367-377-10)", "package_ndc": "69367-377-10", "marketing_start_date": "20250414"}], "brand_name": "Simvastatin", "product_id": "69367-377_5bcccfd7-0ae8-4fad-a535-5efa7b327550", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69367-377", "generic_name": "Simvastatin", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA211394", "marketing_category": "ANDA", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}