miudella

Generic: copper

Labeler: sebela women's health inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name miudella
Generic Name copper
Labeler sebela women's health inc.
Dosage Form INTRAUTERINE DEVICE
Routes
INTRAUTERINE
Active Ingredients

copper 175 mm/1

Manufacturer
Sebela Women's Health Inc.

Identifiers & Regulatory

Product NDC 82686-300
Product ID 82686-300_372773b6-fbed-c74b-e063-6294a90a7bf2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218201
Listing Expiration 2026-12-31
Marketing Start 2025-10-01

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 82686300
Hyphenated Format 82686-300

Supplemental Identifiers

RxCUI
2724423 2724428
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 miudella (source: ndc)
Generic Name copper (source: ndc)
Application Number NDA218201 (source: ndc)
Routes
INTRAUTERINE
source: ndc

Resolved Composition

Strengths
  • 175 mm/1
source: ndc
Packaging
  • 1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY
source: ndc

Packages (1)

82686-300-01 1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY

Ingredients (1)

copper (175 mm/1)

Linked Drug Pages (1)

Miudella ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAUTERINE"], "spl_id": "372773b6-fbed-c74b-e063-6294a90a7bf2", "openfda": {"nui": ["M0005152", "N0000175831", "N0000008595", "N0000008924", "N0000175830"], "unii": ["789U1901C5"], "rxcui": ["2724423", "2724428"], "spl_set_id": ["9f5c5008-8166-40fa-9627-e9aa620b547e"], "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": ["Sebela Women's Health Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01)  / 1 INTRAUTERINE DEVICE in 1 TRAY", "package_ndc": "82686-300-01", "marketing_start_date": "20251001"}], "brand_name": "Miudella", "product_id": "82686-300_372773b6-fbed-c74b-e063-6294a90a7bf2", "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": "82686-300", "generic_name": "Copper", "labeler_name": "Sebela Women's Health Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Miudella", "active_ingredients": [{"name": "COPPER", "strength": "175 mm/1"}], "application_number": "NDA218201", "marketing_category": "NDA", "marketing_start_date": "20251001", "listing_expiration_date": "20261231"}