simvastatin

Generic: simvastatin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4782
Product ID 55154-4782_403c6eb1-a14f-48d9-a329-b1a7a78029b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2026-12-31
Marketing Start 2011-05-02

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 551544782
Hyphenated Format 55154-4782

Supplemental Identifiers

RxCUI
312961
UPC
0055154478205
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
  • 10 BLISTER PACK in 1 BAG (55154-4782-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-4782-0 10 BLISTER PACK in 1 BAG (55154-4782-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "403c6eb1-a14f-48d9-a329-b1a7a78029b7", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0055154478205"], "unii": ["AGG2FN16EV"], "rxcui": ["312961"], "spl_set_id": ["b2d6c7ac-304b-4cba-974c-d9a23a069925"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-4782-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-4782-0", "marketing_start_date": "20110502"}], "brand_name": "Simvastatin", "product_id": "55154-4782_403c6eb1-a14f-48d9-a329-b1a7a78029b7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "55154-4782", "generic_name": "Simvastatin", "labeler_name": "Cardinal Health 107, LLC", "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": "20110502", "listing_expiration_date": "20261231"}