Home NDC 0052-4330-01 Nexplanon
Product NDC 0052-4330
Requested package NDC 0052-4330-01
11-digit product format 000524330
Labeler code 0052
Product ID 0052-4330_275103d5-5887-4cbe-a83e-d6cc11f46732
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etonogestrel
Dosage form IMPLANT
Route SUBCUTANEOUS
Labeler Organon USA Inc.
Application NDA021529
Marketing category NDA
Marketing start 2013-09-27
Marketing end 0000-00-00
Substance ETONOGESTREL
Active strength 68 mg/1
Pharmacologic classes Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nexplanon ETONOGESTREL Organon LLC 487f8a62-e142-457c-97cc-2e398fde7594 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021529 application number: NDA021529
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0052-4330-01 00052433001 1 BLISTER PACK in 1 CARTON (0052-4330-01) > 1 IMPLANT in 1 BLISTER PACK 1 blister pack 2013-09-27 0000-00-00 No No Current