Fulvestrant

Product NDC: 71731-6121
Requested package NDC: 71731-6121-1
11-digit product format: 717316121
Labeler code: 71731
Product ID: 71731-6121_6cfbb5fe-940b-4ff1-89a7-e1dfc42b235b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fulvestrant
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Application: ANDA211422
Marketing category: ANDA
Marketing start: 2021-04-01
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: 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
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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211422-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211422-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211422-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211422-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211422-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211422-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211422-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211422-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211422-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211422-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211422-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211422-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211422-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211422-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211422-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211422-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211422-001	AO	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211422-001	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211422-001	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211422-001	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211422-001	AO	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211422-001	AO	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211422-001	AO	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211422-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211422-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211422-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211422-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211422-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211422-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211422-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211422-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211422-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211422-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211422-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211422-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211422-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211422-001	AO	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fulvestrant
Listing expiration: 2026-12-31

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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
46086fe7-190d-4963-97bc-1fe22d36e6d2	Available on FDA.report

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71731-6121-1	Fulvestrant	2 in 1 CARTON	INJECTION	2		6
71731-6121-1	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
71731-6121	FULVESTRANT INJECTION [CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.]	5	Current NDC, Legacy NDC, 2 package rows	20241230_46086fe7-190d-4963-97bc-1fe22d36e6d2.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 ndc (package): 71731-6121-1 ndc (product): 71731-6121 ndc11 (package): 71731612101
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
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

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	46086fe7-190d-4963-97bc-1fe22d36e6d2	6
727762	5 ML fulvestrant 50 MG/ML Prefilled Syringe	SCD	46086fe7-190d-4963-97bc-1fe22d36e6d2	6
727762	fulvestrant 250 MG per 5 ML Prefilled Syringe	SY	46086fe7-190d-4963-97bc-1fe22d36e6d2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71731-6121-1	71731612101	2 SYRINGE, GLASS in 1 CARTON (71731-6121-1) / 5 mL in 1 SYRINGE, GLASS	2021-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fulvestrant	Chia Tai Tianqing Pharmaceutical Group Co., Ltd. \| Lianyungang Runzhong Pharmaceutical Co., Ltd.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	6