FDA.reportPublic FDA data

Ropivacaine Hydrochloride

Product NDC
55150-197
11-digit product format
551500197
Labeler code
55150
Product ID
55150-197_1e5f1368-058a-492c-b4b7-d9329a7745e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Eugia US LLC
Application
ANDA205612
Marketing category
ANDA
Marketing start
2016-09-15
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1ea46721-9071-6b81-fd0a-a82bfbb014ecProduct name720250220
525701df-f985-480d-995a-e0ee70c2bdf4Product name520250128
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
387afa15-cb51-403a-b2e2-1c9d201e07dcProduct name920230426
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8Product name220220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761Product name520220210
81e34474-b0a5-434f-8104-25d689efc99eProduct name120200303
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39Product name120190408
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
0c7dba41-c919-5809-508d-4affe6cfcff2Product name220170817
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
399647c0-db89-02d1-991c-0c17b584482cProduct name120140508
3e9a6377-704f-dff7-b19f-56c98d40c444Product name120140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1Product name120140508
725d71bf-f956-5cad-e556-fa39cb060dc8Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-197-20Ropivacaine Hydrochloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2010
55150-197-20Ropivacaine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION2510
55150-197-20Ropidex25 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL4
55150-197-20Ropidex20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION20 mL5 mg in 1mL4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-197-20ML - Milliliter55150-197e59ff398-db0f-420d-b9cd-991984b4ed2112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-197ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]8Current NDC, Legacy NDC, 2 package rows20230804_3763b7b6-da49-4658-b93d-28f5da24d09e.zip
55150-197ROPIDEX (DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]4Current NDC, Legacy NDC20241008_2577c1ba-8aff-4098-ba11-a375e9ce3caa.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
1812079dexAMETHasone sodium phosphate 10 MG in 1 ML InjectionPSN2577c1ba-8aff-4098-ba11-a375e9ce3caa4
797730povidone-iodine 10 % Medicated PadPSN2577c1ba-8aff-4098-ba11-a375e9ce3caa4
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN2577c1ba-8aff-4098-ba11-a375e9ce3caa4
18120791 ML dexamethasone phosphate 10 MG/ML InjectionSCD2577c1ba-8aff-4098-ba11-a375e9ce3caa4
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD2577c1ba-8aff-4098-ba11-a375e9ce3caa4
797730povidone-iodine 100 MG/ML Medicated PadSCD2577c1ba-8aff-4098-ba11-a375e9ce3caa4
1812079dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML InjectionSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4
797730povidone-iodine 10 % Medicated PadSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4
797730povidone-iodine 10 % Medicated SwabstickSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4
1734483ropivacaine HCl 0.5 % per 20 ML InjectionSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4
1734483ropivacaine HCl 100 MG per 20 ML InjectionSY2577c1ba-8aff-4098-ba11-a375e9ce3caa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-197-205515001972025 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE2016-09-150000-00-00NoNoCurrent