ICATIBANT (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 69097-664-34

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

FOR SUBCUTANEOUS USE ONLY

Manufactured by:

Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Rx Only

NDC 69097-664-68

Icatibant Injection

30 mg/3 mL (10 mg/mL)

Single-dose Prefilled Syringe

One 3 mL Prefilled Syringe

Manufactured by: Cipla Ltd., India

At M/s. Gland Pharma Limited, India

Manufactured for:

Cipla USA, Inc.

10 Independence Boulevard, Suite 300

Warren, NJ 07059

Cipla

Rx Only

NDC 69097-664-34

Single-dose,

Prefilled Syringe

Icatibant Injection

30 mg/3 mL (10 mg/mL)

FOR SUBCUTANEOUS USE ONLY

Each syringe delivers 30 mg Icatibant equivalent to 34.14 mg Icatibant acetate

Carton contains:

One single-dose, prefilled syringe and one 25 G hypodermic needle.

Full prescribing information with patient injection instructions.

The syringe is closed with a protective cap.

One 3 mL Prefilled Syringe

Cipla

Rx Only

NDC 69097-664-68

Single-dose,

Prefilled Syringe

Icatibant Injection

30 mg/3 mL (10 mg/mL)

FOR SUBCUTANEOUS USE ONLY

Each syringe delivers 30 mg Icatibant equivalent to 34.14 mg Icatibant acetate

Carton contains:

One single-dose, prefilled syringes and one 25 G hypodermic needle.

Full prescribing information with patient injection instructions.

The syringe is closed with a protective cap.

One 3 mL Prefilled Syringe

Cipla

Rx Only

NDC 69097-664-68

Single-dose,

Prefilled Syringe

Icatibant Injection

30 mg/3 mL (10 mg/mL)

FOR SUBCUTANEOUS USE ONLY

Each syringe delivers 30 mg Icatibant equivalent to 34.14 mg Icatibant acetate

Carton contains:

Three cartons, each with one-single-dose, prefilled Syringe and one 25 G hypodermic needle.

Full prescribing information with patient injection instructions.

The syringe is closed with a protective cap.

3 x 3 mL Prefilled Syringes

Cipla

ICATIBANT icatibant injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-664 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ICATIBANT ACETATE (ICATIBANT) ICATIBANT 30 mg in 3 mL

Inactive Ingredients Ingredient Name Strength ACETIC ACID 3.96 mg in 3 mL SODIUM CHLORIDE 22.35 mg in 3 mL SODIUM HYDROXIDE 1.92 mg in 3 mL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69097-664-68 3 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS 1 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (69097-664-68) 2 NDC:69097-664-34 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS 2 3 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (69097-664-34)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212446 07/13/2020

Labeler — Cipla USA Inc. (078719707)

Registrant — Cipla USA Inc. (078719707)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited,Hyderabad, Telangana		918601238	ANALYSIS (69097-664), MANUFACTURE (69097-664), PACK (69097-664)

Establishment
Name	Address	ID/FEI	Operations
BCN Peptides S.A. Pol. Ind. Els Vinyets-Els Fogars II E-08777 Sant Quinti de Mediona (Barcelona) Spain		468203687	API MANUFACTURE (69097-664)

Revised: 05/2022 Cipla USA Inc.