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
NDC Product Code42023-130
Application NumberNDA018261
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateSeptember 9, 2020
Generic Nameoxytocin
INGREDIENTS (3)
OXYTOCINActive
Quantity: 10 [iU] in 1 mL
Code: 1JQS135EYN
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT