Ropivacaine Hydrochloride

Product NDC
0409-9301
11-digit product format
004099301
Labeler code
0409
Product ID
0409-9301_0669f092-f34e-40c2-af54-8004c205032d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA090194
Marketing category
ANDA
Marketing start
2014-09-23
Marketing end
0000-00-00
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-9301-30ML - Milliliter0409-930109097616-1376-42ad-9dfb-f029ec8ca3cc12014-11-05
0409-9301-31ML - Milliliter0409-93010ccf081d-4100-484c-b7f0-aab36f8a277112014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9301-300040993013010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9301-30) > 30 mL in 1 VIAL, SINGLE-DOSE (0409-9301-31) 2014-09-230000-00-00NoNoCurrent