IMPLANON

Product NDC
0052-0272
11-digit product format
000520272
Labeler code
0052
Product ID
0052-0272_28d5d9d6-a604-4b37-ac4e-42fe955988fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etonogestrel
Dosage form
IMPLANT
Route
SUBCUTANEOUS
Labeler
Organon USA Inc.
Application
NDA021529
Marketing category
NDA
Marketing start
2011-09-06
Marketing end
0000-00-00
Substance
ETONOGESTREL
Active strength
68 mg/1
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0052-0272DDiscontinued by firm2026-08-17
excluded packagepackage0052-02720052-0272-01DDiscontinued by firm2026-08-17

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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0052-0272-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0052-0272-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0052-0272-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0052-0272-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0052-0272-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0052-0272-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0052-0272-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0052-0272-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0052-0272-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0052-0272-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0052-0272-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0052-0272-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0052-0272-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0052-0272-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021529-001IMPLANONETONOGESTREL68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17
N021529-002NEXPLANONETONOGESTREL68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021529-00197575522030-07-28U-1Drug product2017-10-04
N021529-00288887452026-08-28Drug product2014-12-03
N021529-002108212772027-05-31Drug product2020-11-16
N021529-00287220372027-09-28Drug product2014-05-15
N021529-00297575522030-07-28U-1Drug product2017-10-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N021529-002D-1992029-01-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17caaa826d4ba7…
2026-08-18 06:07:402026-07N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021529-001IMPLANON68MG/IMPLANTIMPLANT / IMPLANTATION2006-07-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021529-002NEXPLANON68MG/IMPLANTIMPLANT / IMPLANTATIONRLD, RS2011-05-31bb7c543d1eb4…

Observed Orange Book patent history#

Patent history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N021529-00197575522030-07-28U-1Drug product2017-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07N021529-00288887452026-08-28Drug product2014-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07N021529-002108212772027-05-31Drug product2020-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N021529-00287220372027-09-28Drug product2014-05-15caaa826d4ba7…
2026-08-18 06:07:402026-07N021529-00297575522030-07-28U-1Drug product2017-10-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021529-00197575522030-07-28U-1Drug product2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021529-00288887452026-08-28Drug product2014-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021529-002108212772027-05-31Drug product2020-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021529-00287220372027-09-28Drug product2014-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021529-00297575522030-07-28U-1Drug product2017-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-00197575522030-07-28U-1Drug product2017-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-00288887452026-08-28Drug product2014-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-002108212772027-05-31Drug product2020-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-00287220372027-09-28Drug product2014-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021529-00297575522030-07-28U-1Drug product2017-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021529-00197575522030-07-28U-1Drug product2017-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021529-00288887452026-08-28Drug product2014-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021529-002108212772027-05-31Drug product2020-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021529-00287220372027-09-28Drug product2014-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021529-00297575522030-07-28U-1Drug product2017-10-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-00197575522030-07-28U-1Drug product2017-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-00288887452026-08-28Drug product2014-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-002108212772027-05-31Drug product2020-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-00287220372027-09-28Drug product2014-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021529-00297575522030-07-28U-1Drug product2017-10-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-00197575522030-07-28U-1Drug product2017-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-00288887452026-08-28Drug product2014-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-002108212772027-05-31Drug product2020-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-00287220372027-09-28Drug product2014-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021529-00297575522030-07-28U-1Drug product2017-10-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-00197575522030-07-28U-1Drug product2017-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-00288887452026-08-28Drug product2014-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-002108212772027-05-31Drug product2020-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-00287220372027-09-28Drug product2014-05-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021529-00297575522030-07-28U-1Drug product2017-10-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-00197575522030-07-28U-1Drug product2017-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-00288887452026-08-28Drug product2014-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-002108212772027-05-31Drug product2020-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-00287220372027-09-28Drug product2014-05-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021529-00297575522030-07-28U-1Drug product2017-10-042680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N021529-002D-1992029-01-16caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021529-002D-1992029-01-16a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0272-01EA - Each0052-0272b87f5131-077d-4036-bba2-cdf80483229912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
etonogestrelACTIVE INGREDIENT304GTH6RNHIMPLANON (ETONOGESTREL) IMPLANT [ORGANON USA INC.]11
etonogestrelACTIVE MOIETY304GTH6RNHIMPLANON (ETONOGESTREL) IMPLANT [ORGANON USA INC.]11
ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE)INACTIVE INGREDIENTV9BQI51YULIMPLANON (ETONOGESTREL) IMPLANT [ORGANON USA INC.]11
ETHYLENE-VINYL ACETATE COPOLYMER (28% VINYL ACETATE)INACTIVE INGREDIENT8ILA5X28VSIMPLANON (ETONOGESTREL) IMPLANT [ORGANON USA INC.]11

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
NexplanonETONOGESTRELOrganon LLC487f8a62-e142-457c-97cc-2e398fde75942026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021529
application number: NDA021529