simvastatin

Generic: simvastatin

Labeler: biocon pharma inc,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler biocon pharma inc,
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 40 mg/1

Manufacturer
Biocon Pharma Inc,

Identifiers & Regulatory

Product NDC 70377-004
Product ID 70377-004_4d832ba0-8b5c-de5a-246a-a5f30e884bb4
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 70377004
Hyphenated Format 70377-004

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
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 ANDA078034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70377-004-12)
  • 45 TABLET, FILM COATED in 1 BOTTLE (70377-004-13)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70377-004-14)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (70377-004-15)
source: ndc

Packages (4)

70377-004-12 30 TABLET, FILM COATED in 1 BOTTLE (70377-004-12) 70377-004-13 45 TABLET, FILM COATED in 1 BOTTLE (70377-004-13) 70377-004-14 90 TABLET, FILM COATED in 1 BOTTLE (70377-004-14) 70377-004-15 1000 TABLET, FILM COATED in 1 BOTTLE (70377-004-15)

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": "4d832ba0-8b5c-de5a-246a-a5f30e884bb4", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["7b325108-6940-50a7-96b4-822a5206e568"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Biocon Pharma Inc,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70377-004-12)", "package_ndc": "70377-004-12", "marketing_start_date": "20151217"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (70377-004-13)", "package_ndc": "70377-004-13", "marketing_start_date": "20151217"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70377-004-14)", "package_ndc": "70377-004-14", "marketing_start_date": "20151217"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (70377-004-15)", "package_ndc": "70377-004-15", "marketing_start_date": "20151217"}], "brand_name": "Simvastatin", "product_id": "70377-004_4d832ba0-8b5c-de5a-246a-a5f30e884bb4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70377-004", "generic_name": "Simvastatin", "labeler_name": "Biocon Pharma Inc,", "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"}