Rocuronium Bromide

Product NDC
47781-616
11-digit product format
477810616
Labeler code
47781
Product ID
47781-616_3eac2b48-3c72-dd52-a243-d3440e2ffbc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rocuronium bromide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alvogen Inc.
Application
ANDA205656
Marketing category
ANDA
Marketing start
2018-04-27
Marketing end
2021-10-01
Substance
ROCURONIUM BROMIDE
Active strength
10 mg/mL
Pharmacologic classes
Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-616-17ML - Milliliter47781-616b21dc439-263b-46a2-af8f-62cf434adfac12018-06-11
47781-616-20ML - Milliliter47781-616b3b24240-f384-4f75-8472-20d600f0e0bc12018-06-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-616-174778106161710 VIAL, MULTI-DOSE in 1 CARTON (47781-616-17) > 5 mL in 1 VIAL, MULTI-DOSE (47781-616-20) 2018-04-272021-10-01NoNoCurrent