simvastatin

Generic: simvastatin

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 5 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-681
Product ID 16714-681_6c353eba-27f3-43cc-b954-ec659881872f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077691
Listing Expiration 2026-12-31
Marketing Start 2006-12-20

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 16714681
Hyphenated Format 16714-681

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0316714682013 0316714683010 0316714684017 0316714681016 0316714685014
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 ANDA077691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (16714-681-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (16714-681-02)
source: ndc

Packages (2)

16714-681-01 30 TABLET, FILM COATED in 1 BOTTLE (16714-681-01) 16714-681-02 90 TABLET, FILM COATED in 1 BOTTLE (16714-681-02)

Ingredients (1)

simvastatin (5 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": "6c353eba-27f3-43cc-b954-ec659881872f", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0316714682013", "0316714683010", "0316714684017", "0316714681016", "0316714685014"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["0376351b-f1a0-43e5-a0b4-533072c49f39"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (16714-681-01)", "package_ndc": "16714-681-01", "marketing_start_date": "20061220"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (16714-681-02)", "package_ndc": "16714-681-02", "marketing_start_date": "20061220"}], "brand_name": "Simvastatin", "product_id": "16714-681_6c353eba-27f3-43cc-b954-ec659881872f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "16714-681", "generic_name": "Simvastatin", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "5 mg/1"}], "application_number": "ANDA077691", "marketing_category": "ANDA", "marketing_start_date": "20061220", "listing_expiration_date": "20261231"}