Home NDC 70720-951 ZOLADEX
Product NDC 70720-951
11-digit product format 707200951
Labeler code 70720
Product ID 70720-951_a7c38eaa-3f9a-4b24-8634-bdac6138f983
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name goserelin
Dosage form IMPLANT
Route SUBCUTANEOUS
Labeler TerSera Therapeutics LLC
Application NDA020578
Marketing category NDA
Marketing start 2018-01-26
Substance GOSERELIN ACETATE
Active strength 10.8 mg/1
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
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 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 N020578-001 ZOLADEX GOSERELIN ACETATE EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11
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 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020578-001 ZOLADEX EQ 10.8MG BASE IMPLANT / IMPLANTATION RLD, RS 1996-01-11 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.
Additional Listing Data#
Finished product Yes
Brand name base ZOLADEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GOSERELIN ACETATE 10.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6YUU2PV0U8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 211544 Internal RxNorm lookup 314008 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 70720-951-30 ZOLADEX 1 in 1 POUCH IMPLANT 1 8 70720-951-30 ZOLADEX 1 in 1 CARTON IMPLANT 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70720-951 ZOLADEX (GOSERELIN) IMPLANT [TERSERA THERAPEUTICS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20221027_e4cb3c20-2738-400a-b522-3f36f71fe6c5.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 70720-951-30 70720095130 1 POUCH in 1 CARTON (70720-951-30) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE 1 pouch 2018-01-26 0000-00-00 No No Current