FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
55150-201
11-digit product format
551500201
Labeler code
55150
Product ID
55150-201_1e5f1368-058a-492c-b4b7-d9329a7745e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
Eugia US LLC
Application
ANDA205612
Marketing category
ANDA
Marketing start
2016-09-15
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
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 HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui905189, 1734084, 1734090, 1734207, 1734347, 1734475, 1734483

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
55150-201-20Ropivacaine Hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2010
55150-201-20Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-201-20ML - Milliliter55150-20172428fa6-8800-4d80-bdae-87e850553f7812016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-201ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]8Current NDC, Legacy NDC, 2 package rows20230804_3763b7b6-da49-4658-b93d-28f5da24d09e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ROPivacaine HCl 1 % in 10 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN3763b7b6-da49-4658-b93d-28f5da24d09e10
173409010 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ropivacaine HCl 0.5 % per 30 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ropivacaine HCl 0.75 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ropivacaine HCl 1 % per 10 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ropivacaine HCl 1 % per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734090ropivacaine HCl 100 MG per 10 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
905189ropivacaine HCl 150 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734475ropivacaine HCl 150 MG per 30 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734347ropivacaine HCl 200 MG per 100 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734084ropivacaine HCl 200 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10
1734207ropivacaine HCl 40 MG per 20 ML InjectionSY3763b7b6-da49-4658-b93d-28f5da24d09e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-201-205515002012025 VIAL, SINGLE-DOSE in 1 CARTON (55150-201-20) / 20 mL in 1 VIAL, SINGLE-DOSE2016-09-150000-00-00NoNoCurrent