simvastatin

Generic: simvastatin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6459
Product ID 50090-6459_a6bec4e9-7e8c-42b5-861b-4bf87b934118
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 500906459
Hyphenated Format 50090-6459

Supplemental Identifiers

RxCUI
312962
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 ANDA078034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-6459-0)
source: ndc

Packages (1)

50090-6459-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-6459-0)

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": "a6bec4e9-7e8c-42b5-861b-4bf87b934118", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["312962"], "spl_set_id": ["34c8c080-97b5-4580-b8fb-3fd557cdb40a"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-6459-0)", "package_ndc": "50090-6459-0", "marketing_start_date": "20230501"}], "brand_name": "Simvastatin", "product_id": "50090-6459_a6bec4e9-7e8c-42b5-861b-4bf87b934118", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50090-6459", "generic_name": "Simvastatin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "5 mg/1"}], "application_number": "ANDA078034", "marketing_category": "ANDA", "marketing_start_date": "20151217", "listing_expiration_date": "20261231"}