Fulvestrant

Product NDC: 68001-510
Requested package NDC: 68001-510-85
11-digit product format: 680010510
Labeler code: 68001
Product ID: 68001-510_e723e801-b0d6-32b7-e053-2995a90a00ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fulvestrant
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: BluePoint Laboratories
Application: ANDA207754
Marketing category: ANDA
Marketing start: 2021-08-13
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68001-510	68001-510-85	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A207754-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO		2019-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207754-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207754-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2019-08-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207754-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2019-08-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207754-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207754-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207754-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207754-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207754-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207754-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207754-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207754-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207754-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207754-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207754-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207754-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207754-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207754-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207754-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207754-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207754-001	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207754-001	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207754-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207754-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207754-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207754-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207754-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207754-001	AO	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207754-001	AO	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207754-001	AO	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207754-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207754-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207754-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207754-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207754-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207754-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207754-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207754-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207754-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207754-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207754-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207754-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207754-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207754-001	AO	1	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fulvestrant	FULVESTRANT	GLENMARK PHARMACEUTICALS INC., USA	99cf8b69-4c23-4886-80e9-b23e348b5bd7	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207754 application number: ANDA207754

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
22X328QOC4	FULVESTRANT	129453-61-8	FULVESTRANT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-510-85	68001051085	2 SYRINGE, GLASS in 1 CARTON (68001-510-85) > 5 mL in 1 SYRINGE, GLASS (68001-510-86)	2021-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fulvestrant 68001-510	BluePoint Laboratories \| Ajinomoto Althea, Inc. \| Glenmark Pharmaceuticals Inc., USA	2022-10-13	HUMAN PRESCRIPTION DRUG LABEL	3