Home NDC 83831-159 CLIGAVYX
Product NDC 83831-159
11-digit product format 838310159
Labeler code 83831
Product ID 83831-159_29f2a48e-b9af-486e-bc0c-eab3a1ce0b3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Avyxa Pharma, LLC
Application NDA210063
Marketing category NDA
Marketing start 2026-07-01
Substance FULVESTRANT
Active strength 250 mg/5mL
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 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 N210063-001 CLIGAVYX FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RS 2019-08-19
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 · 42 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 N210063-001 CLIGAVYX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RS 2019-08-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N210063-001 CLIGAVYX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RS 2019-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210063-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR 2019-08-19 e64feba35796…
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 CLIGAVYX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FULVESTRANT 250 mg/5mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727762 Internal RxNorm lookup 2745138 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-159-02 83831015902 2 SYRINGE, GLASS in 1 CARTON (83831-159-02) / 5 mL in 1 SYRINGE, GLASS 2026-07-01 No No Current