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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72078-034
Application NumberNDA020630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72078-035
Application NumberNDA020630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72078-036
Application NumberNDA020630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 15, 2022
FDA Product Classification
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