Paclitaxel (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 44567-504-01

5 mL multidose vial

Semisynthetic Paclitaxel Injection, USP

30 mg/5 mL (6 mg/mL)

CAUTION: Dilution required. Read package insert.WARNING: Cytotoxic Agent

Rx only.

30mg VL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 44567-505-01

16.7 mL multidose vial

Semisynthetic Paclitaxel Injection, USP

100 mg/16.7 mL (6 mg/mL)

CAUTION: Dilution required. Read package insert.WARNING: Cytotoxic Agent

Rx only.

100mg VL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 44567-506-01

50 mL multidose vial

Semisynthetic Paclitaxel Injection, USP

300 mg/50 mL (6 mg/mL)

CAUTION: Dilution required. Read package insert.WARNING: Cytotoxic Agent

Rx only.

300mg VL
(click image for full-size original)
PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-504
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-504-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (44567-504-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020262 07/11/2013
PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-505
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-505-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 16.7 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (44567-505-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020262 07/11/2013
PACLITAXEL paclitaxel injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-506
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL (PACLITAXEL) PACLITAXEL 6 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-506-01 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (44567-506-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020262 07/11/2013
Labeler — WG Critical Care, LLC (829274633)

Revised: 10/2019 WG Critical Care, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.