ZOLADEX

Product NDC
50090-3466
11-digit product format
500903466
Labeler code
50090
Product ID
50090-3466_85bc1c89-64e7-49f1-ad4e-a7c634dbf0da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
goserelin acetate
Dosage form
IMPLANT
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA019726
Marketing category
NDA
Marketing start
2018-03-31
Marketing end
0000-00-00
Substance
GOSERELIN ACETATE
Active strength
4 mg/1
Pharmacologic classes
Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct50090-3466IInactivated by FDA2026-10-05
excluded packagepackage50090-346650090-3466-0IInactivated by FDA2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3466-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3466-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3466-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3466-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3466-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3466-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3466-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3466-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3466-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3466-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3466-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3466-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3466-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3466-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3466-01332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019726-001ZOLADEXGOSERELIN ACETATEEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2984e616aacf4f…
2026-08-18 06:07:402026-07N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-293f01610625f2…
2019-09-15 20:21 UTC2019-09N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019726-001ZOLADEXEQ 3.6MG BASEIMPLANT / IMPLANTATIONRLD, RS1989-12-29f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019726-00172202472022-04-09Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019726-00171185522022-04-13Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019726-00172202472022-04-09Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019726-00171185522022-04-13Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019726-00172202472022-04-09Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019726-00171185522022-04-13Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019726-00175009642021-02-26Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019726-00172202472022-04-09Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019726-00171185522022-04-13Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019726-00172202472022-04-09Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019726-00171185522022-04-13Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019726-00175009642021-02-26Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N019726-00172202472022-04-09Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N019726-00171185522022-04-13Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019726-00175009642021-02-26Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019726-00172202472022-04-09Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019726-00171185522022-04-13Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N019726-00175009642021-02-26Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019726-00172202472022-04-09Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N019726-00171185522022-04-13Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019726-00175009642021-02-26Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019726-00172202472022-04-09Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N019726-00171185522022-04-13Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019726-00175009642021-02-26Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N019726-00172202472022-04-09Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N019726-00171185522022-04-13Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N019726-00175009642021-02-26Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N019726-00172202472022-04-09Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N019726-00171185522022-04-13Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N019726-00175009642021-02-26Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N019726-00172202472022-04-09Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N019726-00171185522022-04-13Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N019726-00175009642021-02-26Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N019726-00172202472022-04-09Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N019726-00171185522022-04-13Drug productea99ee380514…
2023-01-26 05:58 UTC2023-01N019726-00172202472022-04-09Drug product3bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N019726-00171185522022-04-13Drug product3bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019726-00172202472022-04-09Drug product3a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019726-00171185522022-04-13Drug product3a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019726-00172202472022-04-09Drug productf41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb7b08b4-2861-8af1-5ba1-9f2677f044e4Product name120140508
bc083894-2d29-b9b5-2359-590584fe1ff6Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3466-0ZOLADEX1 in 1 CARTONIMPLANT16
50090-3466-0ZOLADEX1 in 1 POUCHIMPLANT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3466-0EA - Each50090-3466c0b009d0-f6dc-4314-8d48-6242bee2b03212019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3466ZOLADEX (GOSERELIN ACETATE) IMPLANT [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210417_a906a5bd-d2ec-4e35-8962-c0c86c637630.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOLADEXGOSERELINTerSera Therapeutics LLC294b168b-6e5f-4db9-bf70-d599271458b32026-03-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019726
application number: NDA019726

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310592goserelin 3.6 MG Subcutaneous Drug ImplantPSNa906a5bd-d2ec-4e35-8962-c0c86c6376306
105641Zoladex 3.6 MG subcutaneous Drug ImplantPSNa906a5bd-d2ec-4e35-8962-c0c86c6376306
105641goserelin 3.6 MG Drug Implant [Zoladex]SBDa906a5bd-d2ec-4e35-8962-c0c86c6376306
310592goserelin 3.6 MG Drug ImplantSCDa906a5bd-d2ec-4e35-8962-c0c86c6376306
310592goserelin 3.6 MG (as goserelin acetate 3.8 MG) Drug ImplantSYa906a5bd-d2ec-4e35-8962-c0c86c6376306
105641Zoladex 3.6 MG (as goserelin acetate 3.8 MG) Drug ImplantSYa906a5bd-d2ec-4e35-8962-c0c86c6376306
105641Zoladex 3.6 MG Drug ImplantSYa906a5bd-d2ec-4e35-8962-c0c86c6376306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3466-0500903466001 POUCH in 1 CARTON (50090-3466-0) > 1 IMPLANT in 1 POUCH1 pouch2018-05-300000-00-00NoNoCurrent