Simvastatin

Generic: Simvastatin

Labeler: McKesson Corporation dba SKY Packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name Simvastatin
Generic Name Simvastatin
Labeler McKesson Corporation dba SKY Packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

SIMVASTATIN 5 mg/1

Identifiers & Regulatory

Product NDC 63739-570
Product ID 63739-570_2b9c397c-d049-32af-e063-6294a90ac00d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077691
Marketing Start 2006-12-20
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63739570
Hyphenated Format 63739-570

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
  • 5 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-570-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

63739-570-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-570-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "2b9c397c-d049-32af-e063-6294a90ac00d", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["198211", "312961", "312962", "314231"], "spl_set_id": ["9999f4dc-60be-4c8f-8063-78144ed4431f"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["McKesson Corporation dba SKY Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-570-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63739-570-10", "marketing_end_date": "20260228", "marketing_start_date": "20061220"}], "brand_name": "Simvastatin", "product_id": "63739-570_2b9c397c-d049-32af-e063-6294a90ac00d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "63739-570", "generic_name": "Simvastatin", "labeler_name": "McKesson Corporation dba SKY Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "5 mg/1"}], "application_number": "ANDA077691", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20061220"}