Pitocin
Pitocin (Oxytocin Injection, USP) Synthetic
Approved
Approval ID
6d4b2c25-2e5d-49b5-93bc-2ae8a20916d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2020
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxytocin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-130
Application NumberNDA018261
Product Classification
M
Marketing Category
C73594
G
Generic Name
oxytocin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2020
FDA Product Classification
INGREDIENTS (3)
OXYTOCINActive
Quantity: 10 [iU] in 1 mL
Code: 1JQS135EYN
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT