simvastatin

Generic: simvastatin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-966
Product ID 71610-966_450e6eb7-f49c-296e-e063-6294a90a05a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2007-06-12

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 71610966
Hyphenated Format 71610-966

Supplemental Identifiers

RxCUI
314231
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
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-966-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-966-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-966-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-966-60)
source: ndc

Packages (4)

71610-966-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-966-30) 71610-966-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-966-45) 71610-966-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-966-53) 71610-966-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-966-60)

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": "450e6eb7-f49c-296e-e063-6294a90a05a4", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["314231"], "spl_set_id": ["450e722c-d55d-3e6d-e063-6394a90a5231"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-966-30)", "package_ndc": "71610-966-30", "marketing_start_date": "20251201"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-966-45)", "package_ndc": "71610-966-45", "marketing_start_date": "20251201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71610-966-53)", "package_ndc": "71610-966-53", "marketing_start_date": "20251201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-966-60)", "package_ndc": "71610-966-60", "marketing_start_date": "20251201"}], "brand_name": "SIMVASTATIN", "product_id": "71610-966_450e6eb7-f49c-296e-e063-6294a90a05a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-966", "generic_name": "SIMVASTATIN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20070612", "listing_expiration_date": "20261231"}