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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 018261


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NDA 018261 describes PITOCIN, which is a drug marketed by Ph Health and is included in one NDA. It is available from one supplier. Additional details are available on the PITOCIN profile page.

The generic ingredient in PITOCIN is oxytocin. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the oxytocin profile page.
Summary for 018261
Tradename:PITOCIN
Applicant:Ph Health
Ingredient:oxytocin
Patents:0
Pharmacology for NDA: 018261
Physiological EffectIncreased Uterine Smooth Muscle Contraction or Tone
Medical Subject Heading (MeSH) Categories for 018261
Oxytocics
Suppliers and Packaging for NDA: 018261
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PITOCIN oxytocin INJECTABLE;INJECTION 018261 NDA Endo USA, Inc. 42023-116 42023-116-73 25 VIAL in 1 CARTON (42023-116-73) / 10 mL in 1 VIAL
PITOCIN oxytocin INJECTABLE;INJECTION 018261 NDA Endo USA, Inc. 42023-116 42023-116-83 25 VIAL in 1 CARTON (42023-116-83) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10USP UNITS/ML (10USP UNITS/ML)
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100USP UNITS/10ML (10USP UNITS/ML)
Approval Date:Jul 27, 2007TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500USP UNITS/50ML (10USP UNITS/ML)
Approval Date:Sep 5, 2012TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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