Ropivacaine Hydrochloride

Product NDC
0409-9303
11-digit product format
004099303
Labeler code
0409
Product ID
0409-9303_0669f092-f34e-40c2-af54-8004c205032d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
Hospira, Inc.
Application
ANDA090194
Marketing category
ANDA
Marketing start
2014-09-23
Marketing end
0000-00-00
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
10 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
0409-9303-10ML - Milliliter0409-93035054c669-a9c8-4b7a-91d7-9ddc0516d86312014-11-05
0409-9303-11ML - Milliliter0409-93034e58ab8f-4337-4bd7-a467-d69b828fc81212014-11-05
0409-9303-20ML - Milliliter0409-930365cb5e87-272f-42fd-a243-facb2458b30912014-11-05
0409-9303-21ML - Milliliter0409-93033f688644-fff6-4813-a336-785a52c6f48b12014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-9303-100040993031010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9303-10) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-9303-11) 2014-09-230000-00-00NoNoCurrent
0409-9303-200040993032010 VIAL, SINGLE-DOSE in 1 CARTON (0409-9303-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-9303-21) 2014-09-230000-00-00NoNoCurrent