simvastatin

Generic: simvastatin

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

simvastatin 10 mg/1

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-010
Product ID 42571-010_0369d423-9ef2-0191-e063-6294a90a55e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090383
Listing Expiration 2026-12-31
Marketing Start 2013-06-13

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 42571010
Hyphenated Format 42571-010

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0342571010300 0342571040307 0342571020309 0342571005306 0342571080303
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 ANDA090383 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (42571-010-05)
  • 1000 TABLET in 1 BOTTLE (42571-010-10)
  • 30 TABLET in 1 BOTTLE (42571-010-30)
  • 60 TABLET in 1 BOTTLE (42571-010-60)
  • 90 TABLET in 1 BOTTLE (42571-010-90)
source: ndc

Packages (5)

42571-010-05 500 TABLET in 1 BOTTLE (42571-010-05) 42571-010-10 1000 TABLET in 1 BOTTLE (42571-010-10) 42571-010-30 30 TABLET in 1 BOTTLE (42571-010-30) 42571-010-60 60 TABLET in 1 BOTTLE (42571-010-60) 42571-010-90 90 TABLET in 1 BOTTLE (42571-010-90)

Ingredients (1)

simvastatin (10 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": "0369d423-9ef2-0191-e063-6294a90a55e7", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0342571010300", "0342571040307", "0342571020309", "0342571005306", "0342571080303"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["5c1c694c-4b08-469e-b538-08e69df06146"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (42571-010-05)", "package_ndc": "42571-010-05", "marketing_start_date": "20130613"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42571-010-10)", "package_ndc": "42571-010-10", "marketing_start_date": "20130613"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-010-30)", "package_ndc": "42571-010-30", "marketing_start_date": "20130613"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (42571-010-60)", "package_ndc": "42571-010-60", "marketing_start_date": "20130613"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-010-90)", "package_ndc": "42571-010-90", "marketing_start_date": "20130613"}], "brand_name": "Simvastatin", "product_id": "42571-010_0369d423-9ef2-0191-e063-6294a90a55e7", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "42571-010", "generic_name": "Simvastatin", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA090383", "marketing_category": "ANDA", "marketing_start_date": "20130613", "listing_expiration_date": "20261231"}