simvastatin

Generic: simvastatin

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

Drug Facts

Product Profile

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

simvastatin 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3648
Product ID 70518-3648_468a8b8d-cecf-726b-e063-6294a90a3d51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078034
Listing Expiration 2026-12-31
Marketing Start 2023-02-16

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 705183648
Hyphenated Format 70518-3648

Supplemental Identifiers

RxCUI
314231
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 ANDA078034 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3648-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3648-1)
source: ndc

Packages (2)

70518-3648-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3648-0) 70518-3648-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3648-1)

Ingredients (1)

simvastatin (10 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": "468a8b8d-cecf-726b-e063-6294a90a3d51", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["AGG2FN16EV"], "rxcui": ["314231"], "spl_set_id": ["807e5be4-6f87-48b4-8a3b-e4ad1061e706"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3648-0)", "package_ndc": "70518-3648-0", "marketing_start_date": "20230216"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3648-1)", "package_ndc": "70518-3648-1", "marketing_start_date": "20230221"}], "brand_name": "Simvastatin", "product_id": "70518-3648_468a8b8d-cecf-726b-e063-6294a90a3d51", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-3648", "generic_name": "Simvastatin", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA078034", "marketing_category": "ANDA", "marketing_start_date": "20230216", "listing_expiration_date": "20261231"}