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 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-623
Product ID 71610-623_86b78fe2-ccb5-45de-8746-f8bcbcead975
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078034
Listing Expiration 2026-12-31
Marketing Start 2015-12-17

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 71610623
Hyphenated Format 71610-623

Supplemental Identifiers

RxCUI
198211 312961
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 ANDA078034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-623-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (71610-623-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-623-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-623-60)
source: ndc

Packages (4)

71610-623-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-623-15) 71610-623-30 30 TABLET, FILM COATED in 1 BOTTLE (71610-623-30) 71610-623-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-623-45) 71610-623-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-623-60)

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": "86b78fe2-ccb5-45de-8746-f8bcbcead975", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "312961"], "spl_set_id": ["a753846e-4cd5-4ddc-a4f2-c45da571c883"], "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": "15 TABLET, FILM COATED in 1 BOTTLE (71610-623-15)", "package_ndc": "71610-623-15", "marketing_start_date": "20211206"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71610-623-30)", "package_ndc": "71610-623-30", "marketing_start_date": "20211206"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-623-45)", "package_ndc": "71610-623-45", "marketing_start_date": "20211206"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-623-60)", "package_ndc": "71610-623-60", "marketing_start_date": "20211206"}], "brand_name": "Simvastatin", "product_id": "71610-623_86b78fe2-ccb5-45de-8746-f8bcbcead975", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-623", "generic_name": "Simvastatin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA078034", "marketing_category": "ANDA", "marketing_start_date": "20151217", "listing_expiration_date": "20261231"}