Vitamin K1 (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 0.5 mL Ampul Label — RL-7876

NDC 0409-9157-31

0.5 mL Single-dose Ampul

Rx only

VITAMIN K1 Inj.
Phytonadione Injectable
Emulsion, USP

1 mg/0.5 mL
Neonatal Concentration

Contains no more than 100 mcg/L
of aluminum. Protect from light.

Dist. by Hospira, Inc.,
Lake Forest, IL 60045 USA

Hospira

RL-7876

##-###-AADMMMYYYY

PRINCIPAL DISPLAY PANEL -- 0.5 mL Ampul Label -- RL-7876
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Ampul Tray Label — RL-7129

0.5 mL Single-dose Ampul

Rx only NDC 0409-9157-50
Contains 5 of NDC 0409-9157-31

VITAMIN K1 Injection
Phytonadione Injectable Emulsion, USP

1 mg/0.5 mL
Neonatal Concentration

Protect from light. Keep ampuls in tray until time of use. For
Intramuscular, Subcutaneous, or Intravenous (with caution).

Each mL contains phytonadione 2 mg; polyoxyethylated fatty acid
derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added
as preservative. May contain hydrochloric acid for pH adjustment.
pH 6.3 (5.0 to 7.0). Usual dosage: See insert. Store at 20 to 25°C (68 to
77°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc.,Lake Forest, IL 60045 USA

Hospira

RL-7129

PRINCIPAL DISPLAY PANEL -- 0.5 mL Ampul Tray Label -- RL-7129
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Ampul Label — RL-7875

NDC 0409-9158-31

1 mL only Single-dose Ampul

VITAMIN K1 Inj.

Phytonadione Injectable
Emulsion, USP

10 mg/mL

Contains no more than 110 mcg/L
of aluminum. Protect from light.

Dist. by Hospira, Inc.
Lake Forest, IL 60045 USA

Rx only

RL-7875

##-###-AADMMMYYYY

PRINCIPAL DISPLAY PANEL -- 1 mL Ampul Label -- RL-7875
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Ampul Tray Label — RL-7125

1 mL Single-dose Ampul

Rx only NDC 0409-9158-50
Contains 5 of NDC 0409-9158-31

VITAMIN K1 Injection
Phytonadione Injectable Emulsion, USP

10 mg/mL

Protect from light. Keep ampuls in tray until time of use. For
Intramuscular, Subcutaneous, or Intravenous (with caution).

Each mL contains phytonadione 10 mg; polyoxyethylated fatty acid
derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added
as preservative. May contain hydrochloric acid for pH adjustment.
pH 6.3 (5.0 to 7.0). Usual dosage: See insert. Store at 20 to 25°C (68 to
77°F). [See USP Controlled Room Temperature.]

Distributed by Hospira, Inc.,Lake Forest, IL 60045 USA

Hospira

RL-7125

PRINCIPAL DISPLAY PANEL -- 1 mL Ampul Tray Label -- RL-7125
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Ampul Label — RL-7874

NDC 0409-9158-11
Rx only
1 mL Single-dose Ampul

VITAMIN K1 Inj.
Phytonadione Injectable
Emulsion, USP
10 mg/mL

Contains no more than 110 mcg/L
of aluminum. Protect from light.
Dist. by Hospira, Inc.,
Lake Forest, IL 60045 USA

novaplus

RL-7874

##-###-AADMMMYYYY

PRINCIPAL DISPLAY PANEL -- 1 mL Ampul Label -- RL-7874
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 1 mL Ampul Tray Label — RL-7128

1 mL Single-dose Ampul
Rx only
NDC 0409-9158-55
Contains 5 of NDC 0409-9158-11

VITAMIN K1 Injection
Phytonadione Injectable Emulsion, USP

10 mg/mL

For Intramuscular, Subcutaneous, or Intravenous (with caution).

Protect from light. Keep ampuls in tray until time of use.
Each mL contains phytonadione 10 mg; polyoxyethylated fatty acid
derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added
as preservative. May contain hydrochloric acid for pH adjustment.
pH 6.3 (5.0 to 7.0). Usual dosage: See insert. Store at 20 to 25°C (68 to
77°F). [See USP Controlled Room Temperature.]
Distributed by Hospira, Inc.,
Lake Forest, IL 60045 USA
Novaplus is a registeredtrademark of Vizient, Inc.

novaplus

RL — 7128

PRINCIPAL DISPLAY PANEL -- 1 mL Ampul Tray Label -- RL-4151
(click image for full-size original)
VITAMIN K1 phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9157
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL 70 mg in 1 mL
DEXTROSE MONOHYDRATE 37.5 mg in 1 mL
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9157-01 5 TRAY in 1 CONTAINER contains a TRAY (0409-9157-50)
1 NDC:0409-9157-50 5 AMPULE in 1 TRAY This package is contained within the CONTAINER (0409-9157-01) and contains a AMPULE (0409-9157-31)
1 NDC:0409-9157-31 0.5 mL in 1 AMPULE This package is contained within a TRAY (0409-9157-50) and a CONTAINER (0409-9157-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087954 06/22/2005
VITAMIN K1 phytonadione injection, emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9158
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHYTONADIONE (PHYTONADIONE) PHYTONADIONE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 35 CASTOR OIL 70 mg in 1 mL
DEXTROSE MONOHYDRATE 37.5 mg in 1 mL
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9158-01 5 TRAY in 1 CONTAINER contains a TRAY (0409-9158-50)
1 NDC:0409-9158-50 5 AMPULE in 1 TRAY This package is contained within the CONTAINER (0409-9158-01) and contains a AMPULE (0409-9158-31)
1 NDC:0409-9158-31 1 mL in 1 AMPULE This package is contained within a TRAY (0409-9158-50) and a CONTAINER (0409-9158-01)
2 NDC:0409-9158-25 5 TRAY in 1 CONTAINER contains a TRAY (0409-9158-55)
2 NDC:0409-9158-55 5 AMPULE in 1 TRAY This package is contained within the CONTAINER (0409-9158-25) and contains a AMPULE (0409-9158-11)
2 NDC:0409-9158-11 1 mL in 1 AMPULE This package is contained within a TRAY (0409-9158-55) and a CONTAINER (0409-9158-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087955 07/27/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-9157), ANALYSIS (0409-9158), MANUFACTURE (0409-9157), MANUFACTURE (0409-9158), PACK (0409-9157), PACK (0409-9158), LABEL (0409-9157), LABEL (0409-9158)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-9157), ANALYSIS (0409-9158)
Establishment
Name Address ID/FEI Operations
DSM Nutritional Products AG Zweigniederlassung Werk Sisseln 482688756 ANALYSIS (0409-9157), ANALYSIS (0409-9158), API MANUFACTURE (0409-9157), API MANUFACTURE (0409-9158)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-9157), ANALYSIS (0409-9158)

Revised: 07/2021 Hospira, Inc.

Page 3 of 3 1 2 3

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 © 2022. All Rights Reserved.