Miudella

Product NDC
78206-210
11-digit product format
782060210
Labeler code
78206
Product ID
78206-210_b9fa27ce-06bc-463d-81f3-22b408d2e2f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Copper
Dosage form
INTRAUTERINE DEVICE
Route
INTRAUTERINE
Labeler
Organon LLC
Application
NDA218201
Marketing category
NDA
Marketing start
2025-12-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
2026-09-14 22:38:342026-08N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-2484e616aacf4f…
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 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218201-001101595962032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001101885462032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001118501812032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00194273512032-08-14Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00190894182033-04-09Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001121381992033-10-18Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001103985882034-02-24U-4155Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00196101912034-02-24U-41552025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001100222642034-03-22Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-00191800402034-03-22Drug product2026-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N218201-00192656522034-04-28U-41552025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001101661412034-06-13Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001112072092034-08-16Drug product2025-03-1984e616aacf4f…
2026-09-14 22:38:342026-08N218201-001109185162037-01-23Drug product2025-03-1984e616aacf4f…
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…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218201-001NP2028-02-2484e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Miudella
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COPPER175 mm/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
789U1901C5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2724423Internal RxNorm lookup
2724428Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a75ebac-a765-460d-bb6a-9fbabb0b927dAvailable on FDA.report

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
ndc (product): 78206-210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78206-210-01782060210011 TRAY in 1 BOX, UNIT-DOSE (78206-210-01) / 1 INTRAUTERINE DEVICE in 1 TRAY1 tray2025-12-01NoNoCurrent