Rocuronium Bromide

Product NDC
47781-617
11-digit product format
477810617
Labeler code
47781
Product ID
47781-617_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
2021-12-01
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
47781-617-22ML - Milliliter47781-61746c4832d-691b-4d82-8bfa-247a1484e12312018-06-11
47781-617-91ML - Milliliter47781-6170e16b5a9-47b3-4a80-8628-0dacb6e23b7612018-06-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-617-914778106179110 VIAL, MULTI-DOSE in 1 CARTON (47781-617-91) > 10 mL in 1 VIAL, MULTI-DOSE (47781-617-22) 2018-05-042021-12-01NoNoCurrent