simvastatin

Generic: simvastatin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simvastatin
Generic Name simvastatin
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 20 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-809
Product ID 71205-809_84a02df2-e36f-4505-b0bc-ad8a5d7a0bbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2027-12-31
Marketing Start 2007-06-14

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 71205809
Hyphenated Format 71205-809

Supplemental Identifiers

RxCUI
312961
UPC
0371205809904
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 ANDA078103 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-809-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-809-90)
source: ndc

Packages (2)

71205-809-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-809-30) 71205-809-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-809-90)

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": "84a02df2-e36f-4505-b0bc-ad8a5d7a0bbe", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0371205809904"], "unii": ["AGG2FN16EV"], "rxcui": ["312961"], "spl_set_id": ["8e686832-1caf-425c-9ca6-7eaade43b6fe"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-809-30)", "package_ndc": "71205-809-30", "marketing_start_date": "20260127"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-809-90)", "package_ndc": "71205-809-90", "marketing_start_date": "20230525"}], "brand_name": "SIMVASTATIN", "product_id": "71205-809_84a02df2-e36f-4505-b0bc-ad8a5d7a0bbe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71205-809", "generic_name": "SIMVASTATIN", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20070614", "listing_expiration_date": "20271231"}