Pitocin (Page 3 of 3)

HOW SUPPLIED

Pitocin (Oxytocin Injection, USP) Synthetic is available as follows:

NDC 42023-116-25 Packages of twenty-five oversized 1-mL single-dose vials, each containing 10 units of oxytocin.

NDC 42023-116-02 Packages of twenty-five 10 mL multiple-dose vial, each containing 10 units of oxytocin per mL (total = 100 units of oxytocin per vial).

STORAGE

Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.)

REFERENCES

  1. Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. I. Clinical data. Am J Obstet Gynecol 1982; 144:899–905.
  2. Seitchik J, Castillo M: Oxytocin augmentation of dysfunctional labor. II. Multiparous patients. Am J Obstet Gynecol 1983; 145:777–780.
  3. Fuchs A, Goeschen K, Husslein P, et al: Oxytocin and the initiation of human parturition. III. Plasma concentrations of oxytocin and 13, 14-dihydro-15-keto-prostaglandin F2a in spontaneous and oxytocin-induced labor at term. Am J Obstet Gynecol 1983; 145:497–502.
  4. Seitchik J, Amico J, et al: Oxytocin augmentation of dysfunctional labor. IV. Oxytocin pharmacokinetics. Am J Obstet Gynecol 1984; 150:225–228.
  5. American College of Obstetricians and Gynecologists: ACOG Technical Bulletin Number 110—November 1987: Induction and augmentation of labor.

Rx only.

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

R06/2021

OS116J-01-90-04

3000791J

PRINCIPAL DISPLAY PANEL — 1 mL Vial Label

NDC 42023-116 -25

Pitocin®
(Oxytocin Injection, USP)
Synthetic
10 Units/mL

IV Infusion or IM
1mL Single Dose Vial

1mL SDV Vial Label
(click image for full-size original)

Image 1

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

NDC 42023-116 -02

Pitocin ®
(Oxytocin Injection, USP)
Synthetic

100 units/10 mL (10 units/mL)

For Intravenous Infusion
or Intramuscular Injection

10 mL Multiple Dose Vial

10 mL Vial Label
(click image for full-size original)

Image 2

PITOCIN
oxytocin injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-116
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYTOCIN (OXYTOCIN) OXYTOCIN 10 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
ACETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42023-116-25 25 VIAL in 1 TRAY contains a VIAL
1 1 mL in 1 VIAL This package is contained within the TRAY (42023-116-25)
2 NDC:42023-116-01 1 VIAL in 1 CARTON contains a VIAL
2 10 mL in 1 VIAL This package is contained within the CARTON (42023-116-01)
3 NDC:42023-116-02 25 VIAL in 1 CARTON contains a VIAL
3 10 mL in 1 VIAL This package is contained within the CARTON (42023-116-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018261 02/01/2008
Labeler — Par Pharmaceutical, Inc. (092733690)
Establishment
Name Address ID/FEI Operations
Par Sterile Products LLC 808402890 analysis (42023-116), label (42023-116), manufacture (42023-116), pack (42023-116)

Revised: 06/2021 Par Pharmaceutical, 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.