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
dbc63b6e-f8c5-4fd0-8ec3-4f5e19125313
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 1
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 Code67457-198
Application NumberNDA020630
Product Classification
M
Marketing Category
C73594
G
Generic Name
Remifentanil Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 15, 2021
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