Naropin

Product NDC
63323-286
11-digit product format
633230286
Labeler code
63323
Product ID
63323-286_324532ac-4e54-4659-a1a2-9ade22a1ed3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; PERINEURAL
Labeler
Fresenius Kabi USA, LLC
Application
NDA020533
Marketing category
NDA
Marketing start
2009-08-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naropin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV910P86109
Rxcui1734203, 1734204, 1734207, 1734208, 1734347, 1734348, 1734355, 1734356, 1734475, 1734476, 1734479, 1734480, 1734481, 1734482, 1734483, 1734484

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
63323-286-00Naropin12 in 1 CASEINJECTION, SOLUTION1227
63323-286-01Naropin20 mL in 1 AMPULEINJECTION, SOLUTION2027
63323-286-03Naropin100 mL in 1 BOTTLEINJECTION, SOLUTION10027
63323-286-05Naropin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2027
63323-286-09Naropin30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3027
63323-286-11Naropin30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3027
63323-286-20Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-286-23Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-286-30Naropin30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3027
63323-286-30Naropin1 in 1 BOXINJECTION, SOLUTION127
63323-286-31Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-286-33Naropin200 mL in 1 BOTTLEINJECTION, SOLUTION20027
63323-286-35Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-286-63Naropin12 in 1 CASEINJECTION, SOLUTION1227
63323-286-93Naropin30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION308
63323-286-95Naropin25 in 1 TRAYINJECTION, SOLUTION258
63323-286-27Naropin25 in 1 CARTONINJECTION, SOLUTION256
63323-286-38Naropin25 in 1 CARTONINJECTION, SOLUTION256
63323-286-41Naropin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION206
63323-286-43Naropin30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-286-00ML - Milliliter63323-28630ce4aa1-d8b5-4b2d-babe-357b5041a0fa12012-07-24
63323-286-01ML - Milliliter63323-286ea293a4b-441c-428f-81b0-e23de5e9133412025-09-12
63323-286-05ML - Milliliter63323-2869a18959a-9928-4300-9ec8-7fb749e5afae12021-04-08
63323-286-09ML - Milliliter63323-286ff238a5d-4eba-4781-9818-66c42077d86312021-12-08
63323-286-11ML - Milliliter63323-28673d816fb-0647-4742-85c6-b701ae8658b212019-12-10
63323-286-20ML - Milliliter63323-2866f223830-c0d8-4022-a207-3e8c091e071e12012-07-24
63323-286-23ML - Milliliter63323-28661ad10b7-1306-4744-9e9b-f15c512b20af12013-02-13
63323-286-27ML - Milliliter63323-28619346222-fb8c-49b8-a87f-97d5b93b2e3412014-07-02
63323-286-30ML - Milliliter63323-286a7c054ad-6b68-46ae-bd40-c8634e8b7efb12012-07-24
63323-286-31ML - Milliliter63323-286a3a2352d-2a73-4a8a-9597-dd3d2be7eb7812012-07-24
63323-286-35ML - Milliliter63323-28689ea6505-2416-4e78-bd2e-69f3a79ad35312013-09-04
63323-286-37ML - Milliliter63323-2868b726021-6cfb-45a4-bef9-9cf854c6cca612012-07-24
63323-286-38ML - Milliliter63323-286ec221a34-1c3c-4ee6-a29d-f5956fc5841412013-12-02
63323-286-41ML - Milliliter63323-286c0a29417-7cd8-49b6-9c6c-ef3ca9b679b812024-01-04
63323-286-43ML - Milliliter63323-286ecb18cb9-3d3c-4eca-a56f-c9b2c04cccd312021-04-08
63323-286-63ML - Milliliter63323-286ef84ab42-7ccf-40b3-a33e-9b28797d967412012-07-24
63323-286-93ML - Milliliter63323-286e42de57c-f389-422b-b6f2-39bffa85803012021-04-08
63323-286-95ML - Milliliter63323-2863e9f6cda-aefd-42d4-b6c6-737474af5dd812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-286NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]27Current NDC, Legacy NDC, 14 package rows20240814_23d2d448-a744-4877-9f2d-7e57c198da89.zip
63323-286NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20240817_c6613708-c1f7-4f5c-91a3-ebbc1d7905c6.zip
63323-286NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 4 package rows20240829_dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734204Naropin 0.2 % in 10 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734348Naropin 0.2 % in 100 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734208Naropin 0.2 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734356Naropin 0.2 % in 200 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734480Naropin 0.5 % in 100 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734484Naropin 0.5 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734482Naropin 0.5 % in 200 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734476Naropin 0.5 % in 30 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
905191Naropin 0.75 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734091Naropin 1 % in 10 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734086Naropin 1 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734203ROPivacaine HCl 0.2 % in 10 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734347ROPivacaine HCl 0.2 % in 100 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734207ROPivacaine HCl 0.2 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734355ROPivacaine HCl 0.2 % in 200 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734479ROPivacaine HCl 0.5 % in 100 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734483ROPivacaine HCl 0.5 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734481ROPivacaine HCl 0.5 % in 200 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734475ROPivacaine HCl 0.5 % in 30 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
905189ROPivacaine HCl 0.75 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734090ROPivacaine HCl 1 % in 10 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
1734084ROPivacaine HCl 1 % in 20 ML InjectionPSN23d2d448-a744-4877-9f2d-7e57c198da8927
173409110 ML ropivacaine hydrochloride 10 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173420410 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
1734348100 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
1734480100 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173408620 ML ropivacaine hydrochloride 10 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173420820 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173448420 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
90519120 ML ropivacaine hydrochloride 7.5 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
1734356200 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
1734482200 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173447630 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]SBD23d2d448-a744-4877-9f2d-7e57c198da8927
173409010 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173420310 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
1734347100 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
1734479100 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173408420 ML ropivacaine hydrochloride 10 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173420720 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173448320 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
90518920 ML ropivacaine hydrochloride 7.5 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
1734355200 ML ropivacaine hydrochloride 2 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
1734481200 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173447530 ML ropivacaine hydrochloride 5 MG/ML InjectionSCD23d2d448-a744-4877-9f2d-7e57c198da8927
173409110 ML Naropin 10 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
173420410 ML Naropin 2 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734348100 ML Naropin 2 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734480100 ML Naropin 5 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
173408620 ML Naropin 10 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
173420820 ML Naropin 2 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
173448420 ML Naropin 5 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
90519120 ML Naropin 7.5 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734356200 ML Naropin 2 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734482200 ML Naropin 5 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
173447630 ML Naropin 5 MG/ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734204Naropin 0.2 % per 10 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734348Naropin 0.2 % per 100 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734208Naropin 0.2 % per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734356Naropin 0.2 % per 200 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734480Naropin 0.5 % per 100 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734484Naropin 0.5 % per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734482Naropin 0.5 % per 200 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734476Naropin 0.5 % per 30 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
905191Naropin 0.75 % per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734091Naropin 1 % per 10 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734086Naropin 1 % per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734091Naropin 100 MG per 10 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734484Naropin 100 MG per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734482Naropin 1000 MG per 200 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
905191Naropin 150 MG per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734476Naropin 150 MG per 30 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734204Naropin 20 MG per 10 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734348Naropin 200 MG per 100 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734086Naropin 200 MG per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734208Naropin 40 MG per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734356Naropin 400 MG per 200 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734480Naropin 500 MG per 100 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734203ropivacaine HCl 0.2 % per 10 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734347ropivacaine HCl 0.2 % per 100 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927
1734207ropivacaine HCl 0.2 % per 20 ML InjectionSY23d2d448-a744-4877-9f2d-7e57c198da8927

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-286-006332302860012 BOTTLE in 1 CASE (63323-286-00) / 100 mL in 1 BOTTLE (63323-286-03) 12 bottle2011-05-310000-00-00NoNoCurrent
63323-286-016332302860120 mL in 1 AMPULE20 mlHistorical
63323-286-0363323028603100 mL in 1 BOTTLE100 mlHistorical
63323-286-056332302860520 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-286-096332302860930 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-286-116332302861130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-286-20633230286205 AMPULE in 1 BOX (63323-286-20) / 20 mL in 1 AMPULE (63323-286-01) 5 ampule2011-05-310000-00-00NoNoCurrent
63323-286-236332302862325 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-23) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-05) 2011-05-310000-00-00NoNoCurrent
63323-286-276332302862725 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-41) 2009-08-040000-00-00NoNoCurrent
63323-286-30633230286301 VIAL, SINGLE-DOSE in 1 BOX (63323-286-30) / 30 mL in 1 VIAL, SINGLE-DOSE2011-05-310000-00-00NoNoCurrent
63323-286-31633230286315 VIAL, SINGLE-DOSE in 1 BOX (63323-286-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-09) 2011-05-310000-00-00NoNoCurrent
63323-286-3363323028633200 mL in 1 BOTTLE200 mlHistorical
63323-286-356332302863525 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-35) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-11) 2011-05-310000-00-00NoNoCurrent
63323-286-386332302863825 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-38) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-43) 2009-08-040000-00-00NoNoCurrent
63323-286-416332302864120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-286-436332302864330 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-286-636332302866312 BOTTLE in 1 CASE (63323-286-63) / 200 mL in 1 BOTTLE (63323-286-33) 12 bottle2011-05-310000-00-00NoNoCurrent
63323-286-936332302869330 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
63323-286-956332302869525 VIAL, SINGLE-DOSE in 1 TRAY (63323-286-95) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-93) 2009-08-040000-00-00NoNoCurrent