Oxytocin
Oxytocin Injection, USP (synthetic)
Approved
Approval ID
a9b62187-4141-487c-a9da-f42ad7f9b408
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 2
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 Code0641-6115
Application NumberNDA018243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxytocin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
OXYTOCINActive
Quantity: 10 [USP'U] in 1 mL
Code: 1JQS135EYN
Classification: ACTIB
CHLOROBUTANOLInactive
Quantity: 500 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Oxytocin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6114
Application NumberNDA018243
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxytocin
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (4)
OXYTOCINActive
Quantity: 10 [USP'U] in 1 mL
Code: 1JQS135EYN
Classification: ACTIB
CHLOROBUTANOLInactive
Quantity: 500 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT