Home NDC 68001-626 Fulvestrant
Product NDC 68001-626
11-digit product format 680010626
Labeler code 68001
Product ID 68001-626_3ac255a1-c4ba-46f2-e063-6294a90a0628
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler BluePoint Laboratories.
Application ANDA215077
Marketing category ANDA
Marketing start 2025-01-17
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 A215077-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215077-001 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 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215077-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2022-12-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 68001-626-85 Fulvestrant 2 in 1 CARTON INJECTION 2 3 68001-626-86 Fulvestrant 5 mL in 1 SYRINGE INJECTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-626 FULVESTRANT INJECTION [BLUEPOINT LABORATORIES.] 2 Current NDC, 2 package rows 20250209_57352662-d2fa-4dce-828f-4c51e46e0b4d.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68001-626-85 68001062685 2 SYRINGE in 1 CARTON (68001-626-85) / 5 mL in 1 SYRINGE (68001-626-86) 2 syringe 2025-01-17 No No Current 68001-626-86 68001062686 5 mL in 1 SYRINGE 5 ml Historical