Home NDC 78206-210 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218201-001 MIUDELLA COPPER N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218201-001 10159596 2032-08-14 Drug product 2025-03-19 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 N218201-001 9180040 2034-03-22 Drug product 2026-04-23 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 N218201-001 10918516 2037-01-23 Drug product 2025-03-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N218201-001 NP 2028-02-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218201-001 MIUDELLA N/A SYSTEM / INTRAUTERINE RLD, RS 2025-02-24 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 81 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 9180040 2034-03-22 Drug product 2026-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218201-001 10918516 2037-01-23 Drug product 2025-03-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9180040 2034-03-22 Drug product 2026-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218201-001 10918516 2037-01-23 Drug product 2025-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 10159596 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10188546 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 11850181 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9427351 2032-08-14 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9089418 2033-04-09 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 12138199 2033-10-18 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10398588 2034-02-24 U-4155 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9610191 2034-02-24 U-4155 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10022264 2034-03-22 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 9265652 2034-04-28 U-4155 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 10166141 2034-06-13 Drug product 2025-03-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218201-001 11207209 2034-08-16 Drug product 2025-03-19 011fe1cb6892…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N218201-001 NP 2028-02-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218201-001 NP 2028-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218201-001 NP 2028-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218201-001 NP 2028-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218201-001 NP 2028-02-24 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218201-001 NP 2028-02-24 a50c72e98297…
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 Ingredient Strength COPPER 175 mm/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 789U1901C5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2724423 Internal RxNorm lookup 2724428 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78206-210-01 78206021001 1 TRAY in 1 BOX, UNIT-DOSE (78206-210-01) / 1 INTRAUTERINE DEVICE in 1 TRAY 1 tray 2025-12-01 No No Current