NDC Code(s) : 0069-9141-22, 0069-9141-11, 0069-9142-22, 0069-9142-11, 0069-9144-11
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Docetaxeldocetaxel INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-9141
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS(UNII: 699121PHCA)
(DOCETAXEL ANHYDROUS - UNII:699121PHCA) 		DOCETAXEL ANHYDROUS20 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)518 mg in 2 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)748 mg in 2 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.02 mg in 2 mL
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)7 mg in 2 mL
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-9141-221 in 1 CARTON
12 mL in 1 VIAL, PLASTIC Type 0: Not a Combination Product
2NDC:0069-9141-111 in 1 CARTON
22 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202356 06/23/2014
Docetaxeldocetaxel INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-9142
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS(UNII: 699121PHCA)
(DOCETAXEL ANHYDROUS - UNII:699121PHCA) 		DOCETAXEL ANHYDROUS80 mg in 8 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)2072 mg in 8 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)2992 mg in 8 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.08 mg in 8 mL
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)28 mg in 8 mL
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-9142-221 in 1 CARTON
18 mL in 1 VIAL, PLASTIC Type 0: Not a Combination Product
2NDC:0069-9142-111 in 1 CARTON
28 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202356 06/23/2014
Docetaxeldocetaxel INJECTION, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-9144
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCETAXEL ANHYDROUS(UNII: 699121PHCA)
(DOCETAXEL ANHYDROUS - UNII:699121PHCA) 		DOCETAXEL ANHYDROUS200 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80(UNII: 6OZP39ZG8H)5180 mg in 20 mL
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)7480 mg in 20 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.2 mg in 20 mL
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)70 mg in 20 mL
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-9144-111 in 1 CARTON
120 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202356 06/23/2014

PRINCIPAL DISPLAY PANEL

2 mL single-use vial; discard unused portion

Docetaxel
Injection
20 mg/2 mL (10 mg/mL)

Rx only

Ready to add to infusion solution. Check concentration prior
to preparation. See package insert for complete instructions.

NDC 0069-9141-22
For Intravenous Infusion Only

Caution: Cytotoxic Agent

Pfizer Labs, Division of Pfizer Inc, NY, NY 10017

LOT

EXP
D141PA

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-9141-22
Rx only

2 mL single-use vial;
discard unused portion

Docetaxel
Injection
20 mg/2 mL
(10 mg/mL)

For Intravenous Infusion Only
Caution: Cytotoxic Agent

Ready to add to infusion solution. Check
concentration prior to preparation. See
package insert for complete instructions.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Vial Carton

PRINCIPAL DISPLAY PANEL

2 mL multi-use vial

Docetaxel
Injection
20 mg/2 mL (10 mg/mL)

Rx only

Ready to add to infusion solution. Check concentration prior
to preparation. See package insert for complete instructions.

NDC 0069-9141-11
For Intravenous Infusion Only

Caution: Cytotoxic Agent

Pfizer Labs, Division of Pfizer Inc, NY, NY 10017

LOT

EXP
D147PA

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Multi-Use Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-9141-11
Rx only

2 mL multi-use vial

Docetaxel
Injection
20 mg/2 mL
(10 mg/mL)

For Intravenous Infusion Only
Caution: Cytotoxic Agent

Ready to add to infusion solution. Check
concentration prior to preparation. See
package insert for complete instructions.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 20 mg/2 mL Multi-Use Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-9142-22
8 mL single-use vial;
discard unused portion

Docetaxel
Injection

80 mg/8 mL

(10 mg/mL)

For Intravenous Infusion Only

Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL - 80 mg/8 mL Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-9142-22
Rx only

8 mL single-use vial;
discard unused portion

Docetaxel
Injection
80 mg/8 mL
(10 mg/mL)

For Intravenous Infusion Only
Caution: Cytotoxic Agent

Ready to add to infusion solution. Check
concentration prior to preparation. See
package insert for complete instructions.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 80 mg/8 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-9142-11

8 mL multi-use vial

Docetaxel
Injection

80 mg/8 mL

(10 mg/mL)

For Intravenous Infusion Only

Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL - 80 mg/8 mL Multi-Use Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-9142-11
Rx only

8 mL multi-use vial

Docetaxel
Injection
80 mg/8 mL
(10 mg/mL)

For Intravenous Infusion Only
Caution: Cytotoxic Agent

Ready to add to infusion solution. Check
concentration prior to preparation. See
package insert for complete instructions.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 80 mg/8 mL Multi-Use Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 0069-9144-11

20 mL multi-use vial

Docetaxel
Injection

200 mg/20 mL

(10 mg/mL)

Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Multi-Use Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0069-9144-11
Rx only

20 mL multi-use vial

Docetaxel
Injection
200 mg/20 mL
(10 mg/mL)

For Intravenous Infusion Only
Caution: Cytotoxic Agent

Ready to add to infusion solution. Check
concentration prior to preparation. See
package insert for complete instructions.

Pfizer Injectables

PRINCIPAL DISPLAY PANEL - 200 mg/20 mL Multi-Use Vial Carton