Home NDC 0143-9022 Fulvestrant
Product NDC 0143-9022
11-digit product format 001439022
Labeler code 0143
Product ID 0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA214682
Marketing category ANDA
Marketing start 2022-02-10
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 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 A214682-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214682-001 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 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214682-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2022-02-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214682-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-02-10 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 0143-9022-01 Fulvestrant 5 mL in 1 SYRINGE, GLASS INJECTION 5 4 0143-9022-02 Fulvestrant 2 in 1 CARTON INJECTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9022 FULVESTRANT INJECTION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241122_306c283b-9abe-4985-856b-1957f1f3af8b.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 0143-9022-01 00143902201 5 mL in 1 SYRINGE, GLASS 5 ml Historical 0143-9022-02 00143902202 2 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01) 2022-02-10 0000-00-00 No No Current