FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
0143-9263
11-digit product format
001439263
Labeler code
0143
Product ID
0143-9263_ca74bdef-8c1f-4919-a7e9-a7655953b3af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA214074
Marketing category
ANDA
Marketing start
2025-11-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ropivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui905189, 1734084, 1734207, 1734475

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9263-01Ropivacaine Hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION205
0143-9263-10Ropivacaine Hydrochloride10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9263ROPIVACAINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20230524_35743510-728d-407b-b501-cf019665cd35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN35743510-728d-407b-b501-cf019665cd355
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN35743510-728d-407b-b501-cf019665cd355
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSN35743510-728d-407b-b501-cf019665cd355
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN35743510-728d-407b-b501-cf019665cd355
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD35743510-728d-407b-b501-cf019665cd355
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD35743510-728d-407b-b501-cf019665cd355
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCD35743510-728d-407b-b501-cf019665cd355
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD35743510-728d-407b-b501-cf019665cd355
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
905189ropivacaine HCl 0.75 % per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
1734084ropivacaine HCl 1 % per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
905189ropivacaine HCl 150 MG per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY35743510-728d-407b-b501-cf019665cd355

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9263-010014392630120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
0143-9263-100014392631010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9263-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0143-9263-01) 2025-11-180000-00-00NoNoCurrent