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

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

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.