simvastatin

Generic: simvastatin

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

simvastatin 80 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-733
Product ID 43063-733_414b2bb6-dacf-dcb4-e063-6294a90a8041
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 43063733
Hyphenated Format 43063-733

Supplemental Identifiers

RxCUI
200345
UPC
0343063733301
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
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30)
source: ndc

Packages (1)

43063-733-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30)

Ingredients (1)

simvastatin (80 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": "414b2bb6-dacf-dcb4-e063-6294a90a8041", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0343063733301"], "unii": ["AGG2FN16EV"], "rxcui": ["200345"], "spl_set_id": ["c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30)", "package_ndc": "43063-733-30", "marketing_start_date": "20161228"}], "brand_name": "simvastatin", "product_id": "43063-733_414b2bb6-dacf-dcb4-e063-6294a90a8041", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "43063-733", "generic_name": "simvastatin", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "simvastatin", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA078155", "marketing_category": "ANDA", "marketing_start_date": "20080226", "listing_expiration_date": "20261231"}