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 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4801
Product ID 50090-4801_be40524b-20df-4ee3-b575-1c104364bdcb
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 500904801
Hyphenated Format 50090-4801

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 ANDA077691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50090-4801-0)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4801-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-4801-2)
  • 200 TABLET, FILM COATED in 1 BOTTLE (50090-4801-3)
source: ndc

Packages (4)

50090-4801-0 1000 TABLET, FILM COATED in 1 BOTTLE (50090-4801-0) 50090-4801-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-4801-1) 50090-4801-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-4801-2) 50090-4801-3 200 TABLET, FILM COATED in 1 BOTTLE (50090-4801-3)

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": "be40524b-20df-4ee3-b575-1c104364bdcb", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["312961"], "spl_set_id": ["9133520e-1ffd-4ef1-bced-6b0c9a579f39"], "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": "1000 TABLET, FILM COATED in 1 BOTTLE (50090-4801-0)", "package_ndc": "50090-4801-0", "marketing_start_date": "20230828"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4801-1)", "package_ndc": "50090-4801-1", "marketing_start_date": "20191226"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-4801-2)", "package_ndc": "50090-4801-2", "marketing_start_date": "20191220"}, {"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (50090-4801-3)", "package_ndc": "50090-4801-3", "marketing_start_date": "20230906"}], "brand_name": "Simvastatin", "product_id": "50090-4801_be40524b-20df-4ee3-b575-1c104364bdcb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50090-4801", "generic_name": "Simvastatin", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA077691", "marketing_category": "ANDA", "marketing_start_date": "20061220", "listing_expiration_date": "20261231"}