Pitocin (Page 3 of 3)

HOW SUPPLIED

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

NDC 42023-116-83 Packages of twenty-five oversized 1-mL single-dose vials, each containing 10 units of oxytocin.

NDC 42023-116-73 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

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PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

I05/2023

OS116P-01-95-01

3003990

PRINCIPAL DISPLAY PANEL — 1 mL x 25 Pack

1 mL 25 pack carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mLx 25 pack

10 mL x 25 pack carton
(click image for full-size original)
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:42023-116-83 25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (42023-116-83)
2 NDC:42023-116-73 25 VIAL in 1 CARTON contains a VIAL
2 10 mL in 1 VIAL This package is contained within the CARTON (42023-116-73)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018261 12/22/2023
Labeler — Par Pharmaceutical, Inc. (092733690)
Registrant — Par Sterile Products LLC (804894611)
Establishment
Name Address ID/FEI Operations
Par Sterile Products LLC 808402890 analysis (42023-116), label (42023-116), manufacture (42023-116), pack (42023-116)

Revised: 06/2023 Par Pharmaceutical, Inc.

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