simvastatin

Generic: simvastatin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 80 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-465
Product ID 68180-465_b78d4e8a-2261-43c6-9321-ac2539bdfd2f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2027-12-31
Marketing Start 2016-01-05

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 68180465
Hyphenated Format 68180-465

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0368180478034 0368180464037 0368180479031 0368180465034
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 ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68180-465-03)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68180-465-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68180-465-09)
source: ndc

Packages (3)

68180-465-03 1000 TABLET, FILM COATED in 1 BOTTLE (68180-465-03) 68180-465-06 30 TABLET, FILM COATED in 1 BOTTLE (68180-465-06) 68180-465-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-465-09)

Ingredients (1)

simvastatin (80 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": "b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0368180478034", "0368180464037", "0368180479031", "0368180465034"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["3e48217f-8175-4e9b-9fd0-909be4bbba95"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68180-465-03)", "package_ndc": "68180-465-03", "marketing_start_date": "20160309"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68180-465-06)", "package_ndc": "68180-465-06", "marketing_start_date": "20160105"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68180-465-09)", "package_ndc": "68180-465-09", "marketing_start_date": "20160219"}], "brand_name": "SIMVASTATIN", "product_id": "68180-465_b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68180-465", "generic_name": "SIMVASTATIN", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20160105", "listing_expiration_date": "20271231"}