Naropin

Product NDC: 63323-288
11-digit product format: 633230288
Labeler code: 63323
Product ID: 63323-288_73218c89-8925-468c-84bf-9960b4b3dc3c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA020533
Marketing category: NDA
Marketing start: 2009-08-04
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: 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
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	10 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	V910P86109
Rxcui	1734084, 1734086, 1734090, 1734091, 1734203, 1734204, 1734207, 1734208, 1734347, 1734348, 1734355, 1734356, 1734475, 1734476, 1734479, 1734480, 1734481, 1734482, 1734483, 1734484

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
387afa15-cb51-403a-b2e2-1c9d201e07dc	Product name	9	20230426

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63323-288-01	Naropin	10 mL in 1 AMPULE	INJECTION, SOLUTION	10	27
63323-288-03	Naropin	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	27
63323-288-06	Naropin	20 mL in 1 AMPULE	INJECTION, SOLUTION	20	27
63323-288-07	Naropin	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	27
63323-288-10	Naropin	5 in 1 BOX	INJECTION, SOLUTION	5	27
63323-288-11	Naropin	25 in 1 CARTON	INJECTION, SOLUTION	25	27
63323-288-20	Naropin	5 in 1 BOX	INJECTION, SOLUTION	5	27
63323-288-21	Naropin	25 in 1 CARTON	INJECTION, SOLUTION	25	27
63323-288-23	Naropin	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	8
63323-288-29	Naropin	25 in 1 TRAY	INJECTION, SOLUTION	25	8
63323-288-25	Naropin	20 mL in 1 AMPULE	INJECTION, SOLUTION	20	5
63323-288-27	Naropin	5 in 1 BOX	INJECTION, SOLUTION	5	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-288-01	ML - Milliliter	63323-288	99d30a29-0827-4f56-871e-74fff2b21d2a	1	2025-09-12
63323-288-06	ML - Milliliter	63323-288	0b27ce34-0c40-470b-baa5-cd6d736138a9	1	2021-06-02
63323-288-07	ML - Milliliter	63323-288	e450eecd-0e8b-4c29-8b4e-70132736db56	1	2024-08-12
63323-288-10	ML - Milliliter	63323-288	3332880c-79cc-46fc-b3fe-0d5e98caedb9	1	2012-07-24
63323-288-11	ML - Milliliter	63323-288	cfbf6146-ab02-4290-b393-9e6cf57f0bdb	1	2013-02-13
63323-288-20	ML - Milliliter	63323-288	d1bf23e5-a796-4fd1-be7d-d04e794afc02	1	2012-07-24
63323-288-21	ML - Milliliter	63323-288	28b72b1c-78b4-463a-baf5-f1249b7071d8	1	2013-02-13
63323-288-23	ML - Milliliter	63323-288	57c7d0ae-4b9d-4fa9-a9b4-015794be2d20	1	2024-07-12
63323-288-27	ML - Milliliter	63323-288	67d56f56-df1f-4127-896a-1e29cb3fd63f	1	2014-04-03
63323-288-29	ML - Milliliter	63323-288	f2b1e7d0-d777-41f2-a2a2-b4a33d62a096	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V910P86109	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14
ROPIVACAINE	ACTIVE MOIETY	7IO5LYA57N	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	14
ROPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V910P86109	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
ROPIVACAINE	ACTIVE MOIETY	7IO5LYA57N	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
ROPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V910P86109	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]	1
ROPIVACAINE	ACTIVE MOIETY	7IO5LYA57N	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-288	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	27	Current NDC, Legacy NDC, 8 package rows	20240814_23d2d448-a744-4877-9f2d-7e57c198da89.zip
63323-288	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	8	Current NDC, Legacy NDC, 2 package rows	20240817_c6613708-c1f7-4f5c-91a3-ebbc1d7905c6.zip
63323-288	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240524_56dfabf7-f7a8-4601-b17a-cb16fb995b0f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V910P86109	ROPIVACAINE HYDROCHLORIDE	132112-35-7	ROPIVACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1734204	Naropin 0.2 % in 10 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734348	Naropin 0.2 % in 100 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734208	Naropin 0.2 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734356	Naropin 0.2 % in 200 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734480	Naropin 0.5 % in 100 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734484	Naropin 0.5 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734482	Naropin 0.5 % in 200 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734476	Naropin 0.5 % in 30 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
905191	Naropin 0.75 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734091	Naropin 1 % in 10 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734086	Naropin 1 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734203	ROPivacaine HCl 0.2 % in 10 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734347	ROPivacaine HCl 0.2 % in 100 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734207	ROPivacaine HCl 0.2 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734355	ROPivacaine HCl 0.2 % in 200 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734479	ROPivacaine HCl 0.5 % in 100 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734483	ROPivacaine HCl 0.5 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734481	ROPivacaine HCl 0.5 % in 200 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734475	ROPivacaine HCl 0.5 % in 30 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
905189	ROPivacaine HCl 0.75 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734090	ROPivacaine HCl 1 % in 10 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734084	ROPivacaine HCl 1 % in 20 ML Injection	PSN	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734091	10 ML ropivacaine hydrochloride 10 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734204	10 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734348	100 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734480	100 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734086	20 ML ropivacaine hydrochloride 10 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734208	20 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734484	20 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
905191	20 ML ropivacaine hydrochloride 7.5 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734356	200 ML ropivacaine hydrochloride 2 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734482	200 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734476	30 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]	SBD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734090	10 ML ropivacaine hydrochloride 10 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734203	10 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734347	100 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734479	100 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734084	20 ML ropivacaine hydrochloride 10 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734207	20 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734483	20 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
905189	20 ML ropivacaine hydrochloride 7.5 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734355	200 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734481	200 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734475	30 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734091	10 ML Naropin 10 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734204	10 ML Naropin 2 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734348	100 ML Naropin 2 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734480	100 ML Naropin 5 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734086	20 ML Naropin 10 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734208	20 ML Naropin 2 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734484	20 ML Naropin 5 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
905191	20 ML Naropin 7.5 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734356	200 ML Naropin 2 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734482	200 ML Naropin 5 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734476	30 ML Naropin 5 MG/ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734204	Naropin 0.2 % per 10 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734348	Naropin 0.2 % per 100 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734208	Naropin 0.2 % per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734356	Naropin 0.2 % per 200 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734480	Naropin 0.5 % per 100 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734484	Naropin 0.5 % per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734482	Naropin 0.5 % per 200 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734476	Naropin 0.5 % per 30 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
905191	Naropin 0.75 % per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734091	Naropin 1 % per 10 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734086	Naropin 1 % per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734091	Naropin 100 MG per 10 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734484	Naropin 100 MG per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734482	Naropin 1000 MG per 200 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
905191	Naropin 150 MG per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734476	Naropin 150 MG per 30 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734204	Naropin 20 MG per 10 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734348	Naropin 200 MG per 100 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734086	Naropin 200 MG per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734208	Naropin 40 MG per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734356	Naropin 400 MG per 200 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734480	Naropin 500 MG per 100 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734203	ropivacaine HCl 0.2 % per 10 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734347	ropivacaine HCl 0.2 % per 100 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27
1734207	ropivacaine HCl 0.2 % per 20 ML Injection	SY	23d2d448-a744-4877-9f2d-7e57c198da89	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-288-01	63323028801	10 mL in 1 AMPULE	10 ml					Historical
63323-288-03	63323028803	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
63323-288-06	63323028806	20 mL in 1 AMPULE	20 ml					Historical
63323-288-07	63323028807	20 mL in 1 VIAL, SINGLE-DOSE	20 ml					Historical
63323-288-10	63323028810	5 AMPULE in 1 BOX (63323-288-10) / 10 mL in 1 AMPULE (63323-288-01)	5 ampule	2011-05-31	0000-00-00	No	No	Current
63323-288-11	63323028811	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-288-11) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-288-03)		2011-05-31	0000-00-00	No	No	Current
63323-288-20	63323028820	5 AMPULE in 1 BOX (63323-288-20) / 20 mL in 1 AMPULE (63323-288-06)	5 ampule	2011-05-31	0000-00-00	No	No	Current
63323-288-21	63323028821	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-288-21) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-288-07)		2011-05-31	0000-00-00	No	No	Current
63323-288-23	63323028823	20 mL in 1 VIAL, SINGLE-DOSE	20 ml					Historical
63323-288-25	63323028825	20 mL in 1 AMPULE	20 ml					Historical
63323-288-27	63323028827	5 AMPULE in 1 BOX (63323-288-27) / 20 mL in 1 AMPULE (63323-288-25)	5 ampule	2009-08-04	0000-00-00	No	No	Current
63323-288-29	63323028829	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-288-29) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-288-23)		2009-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naropin	Fresenius Kabi USA, LLC \| Fresenius Kabi Austria \| HP Halden Pharma AS	2024-08-06	HUMAN PRESCRIPTION DRUG LABEL	27
Naropin	Fresenius Kabi USA, LLC	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	8
Naropin (ropivacaine HCl Injection USP)	Fresenius Kabi USA, LLC \| HP Halden Pharma AS	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	5

Naropin

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#