paragard t 380a

Generic: copper

Labeler: coopersurgical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name paragard t 380a
Generic Name copper
Labeler coopersurgical, inc.
Dosage Form INTRAUTERINE DEVICE
Routes
INTRAUTERINE
Active Ingredients

copper 313.4 mg/1

Manufacturer
CooperSurgical, Inc.

Identifiers & Regulatory

Product NDC 59365-5128
Product ID 59365-5128_226b4d58-044f-4016-9da3-6fd6a37645dd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018680
Listing Expiration 2026-12-31
Marketing Start 2017-11-02

Pharmacologic Class

Established (EPC)
copper-containing intrauterine device [epc]
Chemical Structure
copper [cs]
Physiologic Effect
decreased embryonic implantation [pe] decreased sperm motility [pe] inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 593655128
Hyphenated Format 59365-5128

Supplemental Identifiers

RxCUI
2267305 2267310
UNII
789U1901C5
NUI
M0005152 N0000175831 N0000008595 N0000008924 N0000175830

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 paragard t 380a (source: ndc)
Generic Name copper (source: ndc)
Application Number NDA018680 (source: ndc)
Routes
INTRAUTERINE
source: ndc

Resolved Composition

Strengths
  • 313.4 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH
source: ndc

Packages (1)

59365-5128-1 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH

Ingredients (1)

copper (313.4 mg/1)

Linked Drug Pages (1)

ParaGard T 380A ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAUTERINE"], "spl_id": "226b4d58-044f-4016-9da3-6fd6a37645dd", "openfda": {"nui": ["M0005152", "N0000175831", "N0000008595", "N0000008924", "N0000175830"], "unii": ["789U1901C5"], "rxcui": ["2267305", "2267310"], "spl_set_id": ["5ea7ce51-b87a-485e-b841-99466a07a4b2"], "pharm_class_cs": ["Copper [CS]"], "pharm_class_pe": ["Decreased Embryonic Implantation [PE]", "Decreased Sperm Motility [PE]", "Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Copper-containing Intrauterine Device [EPC]"], "manufacturer_name": ["CooperSurgical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (59365-5128-1)  / 1 INTRAUTERINE DEVICE in 1 POUCH", "package_ndc": "59365-5128-1", "marketing_start_date": "20171102"}], "brand_name": "ParaGard T 380A", "product_id": "59365-5128_226b4d58-044f-4016-9da3-6fd6a37645dd", "dosage_form": "INTRAUTERINE DEVICE", "pharm_class": ["Copper [CS]", "Copper-containing Intrauterine Device [EPC]", "Decreased Embryonic Implantation [PE]", "Decreased Sperm Motility [PE]", "Inhibit Ovum Fertilization [PE]"], "product_ndc": "59365-5128", "generic_name": "Copper", "labeler_name": "CooperSurgical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ParaGard T 380A", "active_ingredients": [{"name": "COPPER", "strength": "313.4 mg/1"}], "application_number": "NDA018680", "marketing_category": "NDA", "marketing_start_date": "20171102", "listing_expiration_date": "20261231"}