Ultiva
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1996
Approved
Approval ID
8b4c8696-e23e-4c51-a4d2-babab5bd945a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Remifentanil Hydrochloride
PRODUCT DETAILS
NDC Product Code72078-034
Application NumberNDA020630
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
Generic NameRemifentanil Hydrochloride
INGREDIENTS (3)
Remifentanil HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
GlycineInactive
Quantity: 15 ug in 1 mL
Code: TE7660XO1C
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Remifentanil Hydrochloride
PRODUCT DETAILS
NDC Product Code72078-035
Application NumberNDA020630
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
Generic NameRemifentanil Hydrochloride
INGREDIENTS (3)
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Remifentanil HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
GlycineInactive
Quantity: 15 ug in 1 mL
Code: TE7660XO1C
Classification: IACT
Remifentanil Hydrochloride
PRODUCT DETAILS
NDC Product Code72078-036
Application NumberNDA020630
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
Generic NameRemifentanil Hydrochloride
INGREDIENTS (3)
Remifentanil HydrochlorideActive
Quantity: 1 mg in 1 mL
Code: 5V444H5WIC
Classification: ACTIM
GlycineInactive
Quantity: 15 ug in 1 mL
Code: TE7660XO1C
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT