simvastatin

Generic: simvastatin

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 40 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8056
Product ID 0615-8056_d4f96add-3a0f-4a00-9fa5-d73852230543
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2015-12-02

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 06158056
Hyphenated Format 0615-8056

Supplemental Identifiers

RxCUI
198211
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
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-39)
source: ndc

Packages (2)

0615-8056-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-05) 0615-8056-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-39)

Ingredients (1)

simvastatin (40 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": "d4f96add-3a0f-4a00-9fa5-d73852230543", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211"], "spl_set_id": ["8850724a-a431-46e5-b88e-1d77b0b62d6e"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-05)", "package_ndc": "0615-8056-05", "marketing_start_date": "20190401"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8056-39)", "package_ndc": "0615-8056-39", "marketing_start_date": "20151202"}], "brand_name": "SIMVASTATIN", "product_id": "0615-8056_d4f96add-3a0f-4a00-9fa5-d73852230543", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "0615-8056", "generic_name": "SIMVASTATIN", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20151202", "listing_expiration_date": "20261231"}