Ropivacaine Hydrochloride

Product NDC
0409-9300
11-digit product format
004099300
Labeler code
0409
Product ID
0409-9300_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
2014-11-07
Marketing end
0000-00-00
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
2 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
0409-9300-10ML - Milliliter0409-93009da60741-2e8b-4c58-9860-1c693664260912014-11-05
0409-9300-11ML - Milliliter0409-9300f696669e-5e0d-471f-bce2-2143bba8e72712014-11-05
0409-9300-20ML - Milliliter0409-93009f65cca2-6d65-405c-9e25-edb5c18d7d8612014-11-05
0409-9300-21ML - Milliliter0409-9300fa312a59-6eec-4a37-bfa1-3b52a426fe1612014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9300-100040993001010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-9300-11) 2014-11-070000-00-00NoNoCurrent
0409-9300-200040993002010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9300-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-9300-21) 2014-11-070000-00-00NoNoCurrent