simvastatin

Generic: simvastatin

Labeler: xlcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler xlcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 5 mg/1

Manufacturer
XLCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72865-305
Product ID 72865-305_48bd010d-6429-906e-e063-6394a90ae8b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200895
Listing Expiration 2027-12-31
Marketing Start 2026-01-21

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 72865305
Hyphenated Format 72865-305

Supplemental Identifiers

RxCUI
198211 200345 312961 312962 314231
UPC
0372865307304 0372865308301 0372865309308 0372865305300 0372865306307
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

Packaging Origin

Original Packager
true

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 ANDA200895 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (72865-305-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72865-305-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72865-305-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72865-305-90)
source: ndc

Packages (4)

72865-305-01 100 TABLET, FILM COATED in 1 BOTTLE (72865-305-01) 72865-305-10 1000 TABLET, FILM COATED in 1 BOTTLE (72865-305-10) 72865-305-30 30 TABLET, FILM COATED in 1 BOTTLE (72865-305-30) 72865-305-90 90 TABLET, FILM COATED in 1 BOTTLE (72865-305-90)

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": "48bd010d-6429-906e-e063-6394a90ae8b7", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0372865307304", "0372865308301", "0372865309308", "0372865305300", "0372865306307"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "200345", "312961", "312962", "314231"], "spl_set_id": ["433f8a86-5ad3-43db-8e62-c0812dd3d723"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["XLCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72865-305-01)", "package_ndc": "72865-305-01", "marketing_start_date": "20260121"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72865-305-10)", "package_ndc": "72865-305-10", "marketing_start_date": "20260121"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72865-305-30)", "package_ndc": "72865-305-30", "marketing_start_date": "20260121"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72865-305-90)", "package_ndc": "72865-305-90", "marketing_start_date": "20260121"}], "brand_name": "Simvastatin", "product_id": "72865-305_48bd010d-6429-906e-e063-6394a90ae8b7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72865-305", "generic_name": "Simvastatin", "labeler_name": "XLCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "5 mg/1"}], "application_number": "ANDA200895", "marketing_category": "ANDA", "marketing_start_date": "20260121", "listing_expiration_date": "20271231"}