Home NDC 70860-211 Fulvestrant
Product NDC 70860-211
11-digit product format 708600211
Labeler code 70860
Product ID 70860-211_2cc985f3-36aa-f803-e063-6394a90a06f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fulvestrant
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA211422
Marketing category ANDA
Marketing start 2020-02-18
Marketing end 2026-12-31
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
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 A211422-001 FULVESTRANT FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211422-001 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 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211422-001 FULVESTRANT 50MG/ML INJECTABLE / INTRAMUSCULAR AO 2020-02-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211422-001 FULVESTRANT 250MG/5ML (50MG/ML) SOLUTION / INTRAMUSCULAR AO 2020-02-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fulvestrant 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70860-211-41 Fulvestrant 5 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 5 6 70860-211-74 Fulvestrant 2 in 1 CARTON INJECTION, SOLUTION 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-211 FULVESTRANT INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 6 Current NDC, Legacy NDC, 2 package rows 20250130_8ed06e0e-c17b-4c71-8d03-888bcde4a638.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join fulvestrant FULVESTRANT Sagent Pharmaceuticals d5ae9e07-73b0-4063-a9e4-0ffc5614c2b8 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211422 application number: ANDA211422 Fulvestrant FULVESTRANT Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 46086fe7-190d-4963-97bc-1fe22d36e6d2 2025-12-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211422 application number: ANDA211422 Fulvestrant FULVESTRANT Athenex Pharmaceutical Division, LLC. 8ed06e0e-c17b-4c71-8d03-888bcde4a638 2025-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211422 application number: ANDA211422 ndc (product): 70860-211 fulvestrant FULVESTRANT Sagent Pharmaceuticals 0f05b699-c440-42c1-9557-46759a10ab17 2024-03-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211422 application number: ANDA211422 Fulvestrant FULVESTRANT Avenacy, Inc. f44cffcc-8f5e-4a4c-a36e-ab946ce86266 2024-02-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211422 application number: ANDA211422
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 70860-211-41 70860021141 5 mL in 1 SYRINGE, GLASS 5 ml Historical 70860-211-74 70860021174 2 SYRINGE, GLASS in 1 CARTON (70860-211-74) / 5 mL in 1 SYRINGE, GLASS (70860-211-41) 2020-02-18 2026-12-31 No No Current