OLINVYK
These highlights do not include all the information needed to use OLINVYK safely and effectively. See full prescribing information for OLINVYK.OLINVYK (oliceridine) injection, for intravenous use, CIIInitial U.S. Approval: 2020
Approved
Approval ID
ce167984-8b9d-40b7-84ce-d0f33fff1eaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Trevena, Inc.
DUNS: 827748596
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OLICERIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71308-021
Application NumberNDA210730
Product Classification
M
Marketing Category
C73594
G
Generic Name
OLICERIDINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
OLICERIDINEActive
Quantity: 2 mg in 2 mL
Code: MCN858TCP0
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OLICERIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71308-011
Application NumberNDA210730
Product Classification
M
Marketing Category
C73594
G
Generic Name
OLICERIDINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
OLICERIDINEActive
Quantity: 1 mg in 1 mL
Code: MCN858TCP0
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OLICERIDINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71308-301
Application NumberNDA210730
Product Classification
M
Marketing Category
C73594
G
Generic Name
OLICERIDINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (4)
OLICERIDINEActive
Quantity: 30 mg in 30 mL
Code: MCN858TCP0
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT