Ultiva

Product NDC
67457-198
11-digit product format
674570198
Labeler code
67457
Product ID
67457-198_6daaa2d2-b002-40d3-8a4b-59a460b46053
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Remifentanil Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
NDA020630
Marketing category
NDA
Marketing start
1996-11-06
Marketing end
0000-00-00
Substance
REMIFENTANIL HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-198-00EA - Each67457-198ae602aaa-0867-4da9-83ca-7d4c2ead0aea12015-08-04
67457-198-03EA - Each67457-198f5adc9be-91f5-4f20-a2f4-5c8470a9136112012-07-24
67457-198-05EA - Each67457-198742af89d-b236-4607-91fa-e4e60b4674a112012-07-24
67457-198-10EA - Each67457-198e37f9153-cda1-4b55-967b-244dd1da22ca12012-07-24
67457-198-98EA - Each67457-19814b34d11-4c6e-46f4-b4f1-e87453876e1c12017-03-06
67457-198-99EA - Each67457-19896edceec-8e90-4cc2-b269-bf16f1dc7ab312015-08-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-198-036745701980310 VIAL, GLASS in 1 CARTON (67457-198-03) > 3 mL in 1 VIAL, GLASS (67457-198-00) 1996-11-060000-00-00NoNoCurrent
67457-198-056745701980510 VIAL, GLASS in 1 CARTON (67457-198-05) > 5 mL in 1 VIAL, GLASS (67457-198-99) 1996-11-060000-00-00NoNoCurrent
67457-198-106745701981010 VIAL, GLASS in 1 CARTON (67457-198-10) > 10 mL in 1 VIAL, GLASS (67457-198-98) 1996-11-060000-00-00NoNoCurrent