Fulvestrant Injection

Manufacturer: Zydus Lifesciences Limited
Effective date: 2022-08-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:44:20

Label at a glance#

ProductFULVESTRANT

Active ingredientFULVESTRANT

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1626-2

Fulvestrant Injection

250 mg/5 mL (50 mg/mL)

For Intramuscular Use Only

Both single-dose prefilled syringes must be administered to receive the 500 mg dose.

PROTECT FROM LIGHT

Rx only

Made in India

NDC 70771-1626-8

Fulvestrant Injection

250 mg/5 mL (50 mg/mL)

For Intramuscular Use Only

This carton contains a total of 500 mg fulvestrant in TWO single-dose prefilled syringes each containing 250 mg/5 mL, and two Safety Glide™ shielding intramuscular injection needles.

Discard each syringe after use.

Both single-dose prefilled syringes must be administered to receive the 500 mg dose.

STORAGE: REFRIGERATE 2° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE.

Contains 2 Single-Dose Prefilled Syringes

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
727762	fulvestrant 250 MG in 5 ML Prefilled Syringe	PSN	2
727762	5 ML fulvestrant 50 MG/ML Prefilled Syringe	SCD	2
727762	fulvestrant 250 MG per 5 ML Prefilled Syringe	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FULVESTRANT Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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
70771-1626-2	FULVESTRANT	5 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	5		2
70771-1626-8	FULVESTRANT	2 in 1 CARTON	INJECTION, SOLUTION	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1626	FULVESTRANT INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20221014_151b948a-3106-497a-b1c7-479307faeb89.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

FULVESTRANT
ALCOHOL
BENZYL ALCOHOL
BENZYL BENZOATE
CASTOR OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1626	70771-1626-2, 70771-1626-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FULVESTRANT	22X328QOC4	ACTIB
ALCOHOL	3K9958V90M	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
BENZYL BENZOATE	N863NB338G	IACT
CASTOR OIL	D5340Y2I9G	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A215234-001	FULVESTRANT	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO		2021-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215234-001	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
2026-10-15 13:18:30	2026-09	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR		2021-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215234-001	FULVESTRANT	50MG/ML	INJECTABLE / INTRAMUSCULAR	AO	2021-07-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215234-001	FULVESTRANT	250MG/5ML (50MG/ML)	SOLUTION / INTRAMUSCULAR	AO	2021-07-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A215234-001	AO	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A215234-001	AO	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215234-001	AO	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215234-001	AO	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215234-001	AO	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215234-001	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215234-001	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215234-001	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215234-001	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215234-001	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215234-001	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215234-001	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215234-001	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215234-001	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215234-001	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215234-001	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215234-001	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215234-001	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215234-001	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215234-001	AO	1	`4b0b4de00fa7…`
2021-12-28 21:50 UTC	2021-12	A215234-001	AO	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215234-001	AO	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215234-001	AO	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215234-001	AO	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215234-001	AO	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215234-001	AO	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215234-001	AO	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215234-001	AO	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215234-001	AO	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215234-001	AO	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215234-001	AO	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215234-001	AO	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215234-001	AO	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215234-001	AO	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215234-001	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	Zydus Lifesciences Limited	151b948a-3106-497a-b1c7-479307faeb89	2022-08-26		Exact identifier ndc (package): 70771-1626-8 ndc (package): 70771-1626-2 ndc (product): 70771-1626 ndc11 (package): 70771162608 ndc11 (package): 70771162602 spl id: 6908877d-222b-43e6-a7e9-f264fae84be4 spl set id: 151b948a-3106-497a-b1c7-479307faeb89

Reported adverse events (FAERS/openFDA)#

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