Ropivacaine Hydrochloride

Product NDC
67457-876
11-digit product format
674570876
Labeler code
67457
Product ID
67457-876_7006cce5-a917-4f4d-9620-1933ef256a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Mylan Institutional LLC
Application
ANDA090318
Marketing category
ANDA
Marketing start
2019-05-23
Marketing end
2021-03-31
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
150 mg/30mL
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
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
67457-876-30ML - Milliliter67457-876b21af171-cc0a-4f32-b5a2-3829395ceedf12019-06-19
67457-876-99ML - Milliliter67457-8764f7234d6-1f24-4bf0-b96b-04d18e360ed412022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-876-30674570876301 VIAL in 1 CARTON (67457-876-30) > 30 mL in 1 VIAL1 vial2019-05-232021-03-31NoNoCurrent
67457-876-99674570876995 VIAL in 1 CARTON (67457-876-99) > 30 mL in 1 VIAL5 vial2019-05-232021-03-31NoNoCurrent