Home NDC 16729-436 FULVESTRANT
Product NDC 16729-436
11-digit product format 167290436
Labeler code 16729
Product ID 16729-436_3001d1ed-b200-7d1b-e063-6394a90ab45f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fulvestrant
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Accord Healthcare Inc.
Application ANDA211689
Marketing category ANDA
Marketing start 2021-01-21
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 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 A211689-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211689-001 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 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211689-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-11-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211689-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-11-17 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 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 · 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 16729-436-30 FULVESTRANT 2 in 1 CARTON INJECTION 2 6 16729-436-31 FULVESTRANT 5 mL in 1 SYRINGE, GLASS INJECTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-436 FULVESTRANT INJECTION [ACCORD HEALTHCARE INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250312_b471eb51-488e-5312-e053-2a95a90a8116.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 Marketing end Sample Exclude flag Status 16729-436-30 16729043630 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31) 2021-01-21 0000-00-00 No No Current 16729-436-31 16729043631 5 mL in 1 SYRINGE, GLASS 5 ml Historical