Home NDC 68462-317 Fulvestrant
Product NDC 68462-317
11-digit product format 684620317
Labeler code 68462
Product ID 68462-317_e98586b1-cab4-4f10-bf04-7e92f3ca2ff2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA207754
Marketing category ANDA
Marketing start 2019-08-22
Substance FULVESTRANT
Active strength 50 mg/mL
Pharmacologic classes Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68462-317-32 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68462-317-32 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68462-317-32 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68462-317-32 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68462-317-32 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68462-317-32 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68462-317-32 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68462-317-32 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68462-317-32 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207754-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207754-001 AO
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.
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 2026-02-19 14:30 UTC 2026-02 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207754-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2019-08-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207754-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-08-22 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fulvestrant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FULVESTRANT 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 22X328QOC4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727762 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 68462-317-32 Fulvestrant 2 in 1 CARTON INJECTION 2 8 68462-317-40 Fulvestrant 5 mL in 1 SYRINGE, GLASS INJECTION 5 8
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 68462-317-32 68462031732 2 SYRINGE, GLASS in 1 CARTON (68462-317-32) / 5 mL in 1 SYRINGE, GLASS (68462-317-40) 2019-08-22 0000-00-00 No No Current 68462-317-40 68462031740 5 mL in 1 SYRINGE, GLASS 5 ml Historical