Fulvestrant Injection, Solution
FDA Label NDC 70771-1626

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Fulvestrant (NDC 70771-1626). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Pfs Mfg Label (0e88b518 F3b3 4a43 B795 F6d9dbc3b0c6 01)

Pfs Mfg Label (0e88b518 F3b3 4a43 B795 F6d9dbc3b0c6 01)

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

Carton Mfg Label (0e88b518 F3b3 4a43 B795 F6d9dbc3b0c6 02)

Carton Mfg Label (0e88b518 F3b3 4a43 B795 F6d9dbc3b0c6 02)

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