simvastatin

Generic: simvastatin

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

simvastatin 20 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-014
Product ID 82009-014_1de47781-9000-0fc1-e063-6294a90a8139
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200895
Listing Expiration 2026-12-31
Marketing Start 2022-05-26

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 82009014
Hyphenated Format 82009-014

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0382009015101 0382009013107 0382009014104 0382009012100
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 ANDA200895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (82009-014-10)
source: ndc

Packages (1)

82009-014-10 1000 TABLET, FILM COATED in 1 BOTTLE (82009-014-10)

Ingredients (1)

simvastatin (20 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": "1de47781-9000-0fc1-e063-6294a90a8139", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0382009015101", "0382009013107", "0382009014104", "0382009012100"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["2b4255a7-f9f5-4235-8dbb-b0f03acbd624"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82009-014-10)", "package_ndc": "82009-014-10", "marketing_start_date": "20220526"}], "brand_name": "Simvastatin", "product_id": "82009-014_1de47781-9000-0fc1-e063-6294a90a8139", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-014", "generic_name": "Simvastatin", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA200895", "marketing_category": "ANDA", "marketing_start_date": "20220526", "listing_expiration_date": "20261231"}