Oxytocin
OXYTOCIN INJECTION, USP
Approved
Approval ID
d16a48c5-6b71-40a0-bcda-204f043fe832
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2018
Manufacturers
FDA
West-Ward Pharmaceuticals Corp
DUNS: 001230762
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 Code0143-9743
Application NumberANDA200219
Product Classification
M
Marketing Category
C73584
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
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CHLOROBUTANOLInactive
Quantity: 500 mg in 1 mL
Code: HM4YQM8WRC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Oxytocin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9742
Application NumberANDA200219
Product Classification
M
Marketing Category
C73584
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