zocor

Generic: simvastatin

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zocor
Generic Name simvastatin
Labeler organon llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

simvastatin 10 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-180
Product ID 78206-180_11256523-425c-48e8-afe1-e3a4e28c892e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019766
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

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 78206180
Hyphenated Format 78206-180

Supplemental Identifiers

RxCUI
104490 104491 152923 198211 312961 314231
UPC
0378206182012 0378206180018 0378206181015
UNII
AGG2FN16EV
NUI
N0000175589 N0000000121

Packaging Origin

Original Packager
true

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 zocor (source: ndc)
Generic Name simvastatin (source: ndc)
Application Number NDA019766 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01)
  • 90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02)
source: ndc

Packages (2)

78206-180-01 30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01) 78206-180-02 90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02)

Ingredients (1)

simvastatin (10 mg/1)

Linked Drug Pages (1)

ZOCOR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11256523-425c-48e8-afe1-e3a4e28c892e", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0378206182012", "0378206180018", "0378206181015"], "unii": ["AGG2FN16EV"], "rxcui": ["104490", "104491", "152923", "198211", "312961", "314231"], "spl_set_id": ["8f55d5de-5a4f-4a39-8c84-c53976dd6af9"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (78206-180-01)", "package_ndc": "78206-180-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (78206-180-02)", "package_ndc": "78206-180-02", "marketing_start_date": "20210601"}], "brand_name": "ZOCOR", "product_id": "78206-180_11256523-425c-48e8-afe1-e3a4e28c892e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "78206-180", "generic_name": "SIMVASTATIN", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOCOR", "active_ingredients": [{"name": "SIMVASTATIN", "strength": "10 mg/1"}], "application_number": "NDA019766", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}