simvastatin

Generic: simvastatin

Labeler: st marys medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler st marys medical park pharmacy
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
St Marys Medical Park Pharmacy

Identifiers & Regulatory

Product NDC 60760-005
Product ID 60760-005_2905d8c2-2721-98e3-e063-6394a90af73c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078155
Listing Expiration 2026-12-31
Marketing Start 2008-02-26

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 60760005
Hyphenated Format 60760-005

Supplemental Identifiers

RxCUI
198211 200345 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 ANDA078155 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-005-30)
source: ndc

Packages (1)

60760-005-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-005-30)

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": "2905d8c2-2721-98e3-e063-6394a90af73c", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961"], "spl_set_id": ["a0714ce3-bd46-4536-9b1e-83489c368f40"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["St Marys Medical Park Pharmacy"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-005-30)", "package_ndc": "60760-005-30", "marketing_start_date": "20080226"}], "brand_name": "SIMVASTATIN", "product_id": "60760-005_2905d8c2-2721-98e3-e063-6394a90af73c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "60760-005", "generic_name": "simvastatin", "labeler_name": "St Marys Medical Park Pharmacy", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078155", "marketing_category": "ANDA", "marketing_start_date": "20080226", "listing_expiration_date": "20261231"}