simvastatin

Generic: simvastatin

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-470
Product ID 68645-470_4743ea92-1985-a9f4-e063-6294a90a8cdb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2007-06-01

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 68645470
Hyphenated Format 68645-470

Supplemental Identifiers

RxCUI
198211 312961
UPC
0368645470542 0368645527543
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 ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68645-470-54)
source: ndc

Packages (1)

68645-470-54 30 TABLET, FILM COATED in 1 BOTTLE (68645-470-54)

Ingredients (1)

simvastatin (20 mg/1)

Linked Drug Pages (1)

Simvastatin, SIMVASTATIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4743ea92-1985-a9f4-e063-6294a90a8cdb", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0368645470542", "0368645527543"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "312961"], "spl_set_id": ["462cc021-2c48-4665-b9a9-f293d153fb03"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68645-470-54)", "package_ndc": "68645-470-54", "marketing_start_date": "20070601"}], "brand_name": "Simvastatin", "product_id": "68645-470_4743ea92-1985-a9f4-e063-6294a90a8cdb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68645-470", "generic_name": "Simvastatin", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20070601", "listing_expiration_date": "20261231"}