Miudella

Product NDC
82686-300
11-digit product format
826860300
Labeler code
82686
Product ID
82686-300_372773b6-fbed-c74b-e063-6294a90a7bf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Copper
Dosage form
INTRAUTERINE DEVICE
Route
INTRAUTERINE
Labeler
Sebela Women's Health Inc.
Application
NDA218201
Marketing category
NDA
Marketing start
2025-10-01
Substance
COPPER
Active strength
175 mm/1
Pharmacologic classes
Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82686-300DDiscontinued by firm2026-08-17
excluded packagepackage82686-30082686-300-01DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218201-001MIUDELLACOPPERN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218201-001101595962032-08-14Drug product2025-03-19
N218201-001101885462032-08-14Drug product2025-03-19
N218201-001118501812032-08-14Drug product2025-03-19
N218201-00194273512032-08-14Drug product2025-03-19
N218201-00190894182033-04-09Drug product2025-03-19
N218201-001121381992033-10-18Drug product2025-03-19
N218201-001103985882034-02-24U-4155Drug product2025-03-19
N218201-00196101912034-02-24U-41552025-03-19
N218201-001100222642034-03-22Drug product2025-03-19
N218201-00191800402034-03-22Drug product2026-04-23
N218201-00192656522034-04-28U-41552025-03-19
N218201-001101661412034-06-13Drug product2025-03-19
N218201-001112072092034-08-16Drug product2025-03-19
N218201-001109185162037-01-23Drug product2025-03-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218201-001NP2028-02-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 67 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N218201-001101595962032-08-14Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001101885462032-08-14Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001118501812032-08-14Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-00194273512032-08-14Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-00190894182033-04-09Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001121381992033-10-18Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001103985882034-02-24U-4155Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-00196101912034-02-24U-41552025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001100222642034-03-22Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-00191800402034-03-22Drug product2026-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-00192656522034-04-28U-41552025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001101661412034-06-13Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001112072092034-08-16Drug product2025-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07N218201-001109185162037-01-23Drug product2025-03-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218201-001101595962032-08-14Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001101885462032-08-14Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001118501812032-08-14Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-00194273512032-08-14Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-00190894182033-04-09Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001121381992033-10-18Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001103985882034-02-24U-4155Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-00196101912034-02-24U-41552025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001100222642034-03-22Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-00192656522034-04-28U-41552025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001101661412034-06-13Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001112072092034-08-16Drug product2025-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218201-001109185162037-01-23Drug product2025-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001101595962032-08-14Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001101885462032-08-14Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001118501812032-08-14Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-00194273512032-08-14Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-00190894182033-04-09Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001121381992033-10-18Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001103985882034-02-24U-4155Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-00196101912034-02-24U-41552025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001100222642034-03-22Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-00192656522034-04-28U-41552025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001101661412034-06-13Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001112072092034-08-16Drug product2025-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001109185162037-01-23Drug product2025-03-1931067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N218201-001NP2028-02-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218201-001NP2028-02-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218201-001NP2028-02-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N218201-001NP2028-02-246a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218201-001NP2028-02-24a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82686-300-01Miudella1 in 1 BOX, UNIT-DOSEINTRAUTERINE DEVICE15
82686-300-01Miudella1 in 1 TRAYINTRAUTERINE DEVICE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82686-300-01EA - Each82686-3007cc7027a-333e-4ac6-95da-ae12c666f14e12025-05-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiudellaCOPPEROrganon LLC4a75ebac-a765-460d-bb6a-9fbabb0b927d2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 218201
application number: NDA218201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724423copper 1.75 SQCM Intrauterine ImplantPSN9f5c5008-8166-40fa-9627-e9aa620b547e5
2724428Miudella 1.75 SQCM Intrauterine ImplantPSN9f5c5008-8166-40fa-9627-e9aa620b547e5
2724428copper 1.75 SQCM Drug Implant [Miudella]SBD9f5c5008-8166-40fa-9627-e9aa620b547e5
2724423copper 1.75 SQCM Drug ImplantSCD9f5c5008-8166-40fa-9627-e9aa620b547e5
2724423copper 175 mm2 ImplantSY9f5c5008-8166-40fa-9627-e9aa620b547e5
2724428Miudella 1.75 SQCM Drug ImplantSY9f5c5008-8166-40fa-9627-e9aa620b547e5
2724428Miudella 175 mm2 ImplantSY9f5c5008-8166-40fa-9627-e9aa620b547e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82686-300-01826860300011 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY1 tray2025-10-01NoNoHistorical