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 40 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-304
Product ID 72789-304_4bbbb5c9-6c29-bc3b-e063-6294a90a6cce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078103
Listing Expiration 2027-12-31
Marketing Start 2016-02-19

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 72789304
Hyphenated Format 72789-304

Supplemental Identifiers

RxCUI
198211
UPC
0372789304908
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
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-90)
source: ndc

Packages (2)

72789-304-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-30) 72789-304-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-90)

Ingredients (1)

simvastatin (40 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": "4bbbb5c9-6c29-bc3b-e063-6294a90a6cce", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0372789304908"], "unii": ["AGG2FN16EV"], "rxcui": ["198211"], "spl_set_id": ["00896fff-081d-4553-be8c-1999a8a73dda"], "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 (72789-304-30)", "package_ndc": "72789-304-30", "marketing_start_date": "20230410"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-90)", "package_ndc": "72789-304-90", "marketing_start_date": "20220301"}], "brand_name": "SIMVASTATIN", "product_id": "72789-304_4bbbb5c9-6c29-bc3b-e063-6294a90a6cce", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72789-304", "generic_name": "SIMVASTATIN", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SIMVASTATIN", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA078103", "marketing_category": "ANDA", "marketing_start_date": "20160219", "listing_expiration_date": "20271231"}