Home NDC 50090-3466-0 ZOLADEX
Product NDC 50090-3466
Requested package NDC 50090-3466-0
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 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019726-001 ZOLADEX GOSERELIN ACETATE EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29
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 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 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019726-001 ZOLADEX EQ 3.6MG BASE IMPLANT / IMPLANTATION RLD, RS 1989-12-29 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 45 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3466-0 ZOLADEX 1 in 1 CARTON IMPLANT 1 6 50090-3466-0 ZOLADEX 1 in 1 POUCH IMPLANT 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3466 ZOLADEX (GOSERELIN ACETATE) IMPLANT [A-S MEDICATION SOLUTIONS] 6 Legacy NDC, 2 package rows 20210417_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZOLADEX GOSERELIN TerSera Therapeutics LLC 294b168b-6e5f-4db9-bf70-d599271458b3 2026-03-24 Warnings, Adverse reactions Exact identifier application applno (NDA): 019726 application number: NDA019726
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 50090-3466-0 50090346600 1 POUCH in 1 CARTON (50090-3466-0) > 1 IMPLANT in 1 POUCH 1 pouch 2018-05-30 0000-00-00 No No Current