Ropivacaine Hydrochloride

Product NDC
0409-9302
11-digit product format
004099302
Labeler code
0409
Product ID
0409-9302_0669f092-f34e-40c2-af54-8004c205032d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; PERINEURAL
Labeler
Hospira, Inc.
Application
ANDA090194
Marketing category
ANDA
Marketing start
2014-09-23
Marketing end
0000-00-00
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
8 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
0409-9302-20ML - Milliliter0409-9302d72b3392-a119-4725-87be-b56b9106bdd612014-11-05
0409-9302-21ML - Milliliter0409-930240e40051-839e-4875-917b-f04fcf6b144512014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9302-200040993022010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9302-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-9302-21) 2014-09-230000-00-00NoNoCurrent