Home NDC 63323-715 Fulvestrant
Product NDC 63323-715
11-digit product format 633230715
Labeler code 63323
Product ID 63323-715_c584c51e-3ce0-4682-a4dd-d0ac149201a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Fresenius Kabi USA, LLC
Application NDA210326
Marketing category NDA
Marketing start 2019-05-20
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 2026-12-31
Current FDA listing Yes 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 N210326-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N210326-001 AO
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2019-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210326-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-05-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210326-001 9833459 2034-02-14 U-2540 Drug product 2019-06-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210326-001 9271990 2034-05-17 U-2540 Drug product 2019-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210326-001 10188663 2034-02-14 U-2540 Drug product 2019-06-19 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base Fulvestrant
Listing expiration 2026-12-31 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 63323-715-01 Fulvestrant 5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 5 6 63323-715-05 Fulvestrant 2 in 1 CARTON INJECTION, SOLUTION 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-715 FULVESTRANT (FULVESTRANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 2 package rows 20240308_fabe9bd8-ac23-4df1-a89a-223d5cd38914.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 63323-715-01 63323071501 5 mL in 1 SYRINGE, GLASS 5 ml Historical 63323-715-05 63323071505 2 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01) 2019-05-20 0000-00-00 No No Current