Home NDC 78206-145 Nexplanon
Product NDC 78206-145
11-digit product format 782060145
Labeler code 78206
Product ID 78206-145_11bdb463-b672-4e94-993d-bd1b22dc6654
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etonogestrel
Dosage form IMPLANT
Route SUBCUTANEOUS
Labeler Organon LLC
Application NDA021529
Marketing category NDA
Marketing start 2021-06-01
Substance ETONOGESTREL
Active strength 68 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021529-001 IMPLANON ETONOGESTREL 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 N021529-002 NEXPLANON ETONOGESTREL 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021529-002 D-199 2029-01-16
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021529-001 IMPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION 2006-07-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021529-002 NEXPLANON 68MG/IMPLANT IMPLANT / IMPLANTATION RLD, RS 2011-05-31 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 6 · 205 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-001 9757552 2030-07-28 U-1 Drug product 2017-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-002 8888745 2026-08-28 Drug product 2014-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-002 10821277 2027-05-31 Drug product 2020-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-002 8722037 2027-09-28 Drug product 2014-05-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021529-002 9757552 2030-07-28 U-1 Drug product 2017-10-04 2680178bc6a6…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N021529-002 D-199 2029-01-16 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021529-002 D-199 2029-01-16 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Nexplanon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETONOGESTREL 68 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 304GTH6RNH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 389221 Internal RxNorm lookup 1111011 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-145-01 Nexplanon 1 in 1 BLISTER PACK IMPLANT 1 11 78206-145-01 Nexplanon 1 in 1 CARTON IMPLANT 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-145 NEXPLANON (ETONOGESTREL) IMPLANT [ORGANON LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241215_487f8a62-e142-457c-97cc-2e398fde7594.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78206-145-01 78206014501 1 BLISTER PACK in 1 CARTON (78206-145-01) / 1 IMPLANT in 1 BLISTER PACK 1 blister pack 2021-06-01 0000-00-00 No No Current