simvastatin

Generic: simvastatin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-421
Product ID 72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2023-02-07

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 72189421
Hyphenated Format 72189-421

Supplemental Identifiers

RxCUI
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 ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-421-90)
source: ndc

Packages (2)

72189-421-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30) 72189-421-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-421-90)

Ingredients (1)

simvastatin (20 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": "2c4cfec2-fee2-e007-e063-6294a90a3cf9", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["312961"], "spl_set_id": ["f42246de-62d2-212f-e053-2a95a90ac88a"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30)", "package_ndc": "72189-421-30", "marketing_start_date": "20230207"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-421-90)", "package_ndc": "72189-421-90", "marketing_start_date": "20230207"}], "brand_name": "Simvastatin", "product_id": "72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-421", "generic_name": "Simvastatin", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20230207", "listing_expiration_date": "20261231"}