Home NDC 0310-0720 FASLODEX
Product NDC 0310-0720
11-digit product format 003100720
Labeler code 0310
Product ID 0310-0720_9541dd80-09f9-4d3c-bb2a-fc354e198a2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler AstraZeneca Pharmaceuticals LP
Application NDA021344
Marketing category NDA
Marketing start 2010-11-01
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021344-001 FASLODEX FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 N021344-002 FASLODEX FULVESTRANT 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021344-001 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.
Product history page 1 of 2 · 66 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 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021344-001 FASLODEX 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO RLD, RS 2002-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021344-002 FASLODEX 125MG/2.5ML (50MG/ML) SOLUTION / INTRAMUSCULAR RLD 2002-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021344-001 FASLODEX 50MG/ML INJECTABLE / INTRAMUSCULAR AO RLD, RS 2002-04-25 b00525d2431f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 216 observed states.
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base FASLODEX
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727762 Internal RxNorm lookup 727954 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 0310-0720-10 FASLODEX 5 mL in 1 SYRINGE, GLASS INJECTION 5 43 0310-0720-10 FASLODEX 2 in 1 CARTON INJECTION 2 43
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-0720 FASLODEX (FULVESTRANT) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] 40 Current NDC, Legacy NDC, 2 package rows 20240515_83d7a440-e904-4e36-afb5-cb02b1c919f7.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 Marketing start Marketing end Sample Exclude flag Status 0310-0720-10 00310072010 2 SYRINGE, GLASS in 1 CARTON (0310-0720-10) / 5 mL in 1 SYRINGE, GLASS 2010-11-01 0000-00-00 No No Current