simvastatin

Generic: simvastatin

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

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 80 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-3408
Product ID 63629-3408_8898906b-2d01-44bb-9ebc-b7c7f30e11a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078155
Listing Expiration 2026-12-31
Marketing Start 2008-02-26

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 636293408
Hyphenated Format 63629-3408

Supplemental Identifiers

RxCUI
200345
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

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 ANDA078155 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3)
  • 100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4)
  • 10 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5)
source: ndc

Packages (5)

63629-3408-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1) 63629-3408-2 60 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2) 63629-3408-3 90 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3) 63629-3408-4 100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4) 63629-3408-5 10 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5)

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": "8898906b-2d01-44bb-9ebc-b7c7f30e11a6", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["200345"], "spl_set_id": ["b6d5fb21-a1a8-53e5-80d9-dde0eede5ef5"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-3408-1)", "package_ndc": "63629-3408-1", "marketing_start_date": "20240808"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63629-3408-2)", "package_ndc": "63629-3408-2", "marketing_start_date": "20240808"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63629-3408-3)", "package_ndc": "63629-3408-3", "marketing_start_date": "20100927"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (63629-3408-4)", "package_ndc": "63629-3408-4", "marketing_start_date": "20090218"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63629-3408-5)", "package_ndc": "63629-3408-5", "marketing_start_date": "20240808"}], "brand_name": "simvastatin", "product_id": "63629-3408_8898906b-2d01-44bb-9ebc-b7c7f30e11a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "63629-3408", "generic_name": "simvastatin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA078155", "marketing_category": "ANDA", "marketing_start_date": "20080226", "listing_expiration_date": "20261231"}