Fulvestrant Injection

Fulvestrant Injection
SPL v2
SPL
SPL Set ID 151b948a-3106-497a-b1c7-479307faeb89
Route
INTRAMUSCULAR
Published
Effective Date 2022-10-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fulvestrant (50 mg)
Inactive Ingredients
Alcohol Benzyl Alcohol Benzyl Benzoate Castor Oil

Identifiers & Packaging

Marketing Status
ANDA Active Since 2021-12-14
Description

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

Medication Information

Description

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

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:37:19.844677 · Updated: 2026-03-14T21:49:42.549823