FDA.reportPublic FDA data

Miudella

Product NDC
78206-210
11-digit product format
782060210
Labeler code
78206
Product ID
78206-210_27f852b0-5824-49c5-ad60-ae271f23acd4
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 44.

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
2026-10-15 13:18:302026-09N218201-001MIUDELLAN/ASYSTEM / INTRAUTERINERLD, RS2025-02-24c2088c7a36db…
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 · 95 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N218201-001101595962032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001101885462032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001118501812032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00194273512032-08-14Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00190894182033-04-09Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001121381992033-10-18Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001103985882034-02-24U-4155Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00196101912034-02-24U-41552025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001100222642034-03-22Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00191800402034-03-22Drug product2026-04-23c2088c7a36db…
2026-10-15 13:18:302026-09N218201-00192656522034-04-28U-41552025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001101661412034-06-13Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001112072092034-08-16Drug product2025-03-19c2088c7a36db…
2026-10-15 13:18:302026-09N218201-001109185162037-01-23Drug product2025-03-19c2088c7a36db…
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…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N218201-001NP2028-02-24c2088c7a36db…
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

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