Fulvestrant

Product NDC: 43598-262
Requested package NDC: 43598-262-02
11-digit product format: 435980262
Labeler code: 43598
Product ID: 43598-262_711b8216-a850-2e78-bdb1-68c98787e8e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fulvestrant
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Dr.Reddy's Laboratories Inc
Application: ANDA209246
Marketing category: ANDA
Marketing start: 2023-12-31
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
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	43598-262	43598-262-02	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209246-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO		2020-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209246-001	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
2026-09-14 22:38:34	2026-08	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209246-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2020-08-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209246-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2020-08-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209246-001	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209246-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209246-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209246-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209246-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209246-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209246-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209246-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209246-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209246-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209246-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209246-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209246-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209246-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209246-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209246-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209246-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209246-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209246-001	AO	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209246-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209246-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209246-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209246-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209246-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209246-001	AO	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209246-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209246-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209246-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209246-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209246-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209246-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209246-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209246-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209246-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209246-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209246-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209246-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209246-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209246-001	AO	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Fulvestrant
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FULVESTRANT	50 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a809a83e-b49f-c569-2b4b-23ba590406b3	Product name	8	20240208
15aad051-0f67-42b5-934c-5fc8a73abade	Product name	1	20200213
3e4adb99-b829-4f50-ab9b-1e9b483563f6	Product name	1	20190821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43598-262-02	Fulvestrant	2 in 1 CARTON	INJECTION, SOLUTION	2	19
43598-262-11	Fulvestrant	5 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	5	19
43598-262-23	Fulvestrant	2 in 1 CARTON	INJECTION, SOLUTION	2	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-262-02	ML - Milliliter	43598-262	ffea5f6c-7731-4740-a3f9-edad8d056f49	1	2020-09-14
43598-262-11	ML - Milliliter	43598-262	03ff9a88-c9c3-4495-be64-9a6c0bc83841	1	2020-09-14
43598-262-23	ML - Milliliter	43598-262	a0670a5a-4694-44ec-9686-8ad954149217	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-262	FULVESTRANT INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]	19	Current NDC, Legacy NDC, 3 package rows	20240906_2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fulvestrant	FULVESTRANT	Dr.Reddy's Laboratories Inc	2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209246 application number: ANDA209246 ndc (package): 43598-262-02 ndc (product): 43598-262 ndc11 (package): 43598026202

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727762	fulvestrant 250 MG in 5 ML Prefilled Syringe	PSN	2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682	19
727762	5 ML fulvestrant 50 MG/ML Prefilled Syringe	SCD	2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682	19
727762	fulvestrant 250 MG per 5 ML Prefilled Syringe	SY	2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-262-02	43598026202	2 SYRINGE, GLASS in 1 CARTON (43598-262-02) > 5 mL in 1 SYRINGE, GLASS (43598-262-11)	2020-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fulvestrant	Dr.Reddy's Laboratories Inc \| Dr.Reddy's Laboratories Limited-FTO-9	2025-11-01	HUMAN PRESCRIPTION DRUG LABEL	20