Naropin

Product NDC: 63323-287
11-digit product format: 633230287
Labeler code: 63323
Product ID: 63323-287_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA020533
Marketing category: NDA
Marketing start: 1996-09-24
Substance: ROPIVACAINE HYDROCHLORIDE
Active strength: 7.5 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
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	7.5 mg/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	V910P86109
Rxcui	905189, 905191, 1734084, 1734086, 1734090, 1734091, 1734203, 1734204, 1734207, 1734208, 1734347, 1734348, 1734355, 1734356, 1734475, 1734476, 1734479, 1734480, 1734481, 1734482

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
63323-287-01	Naropin	20 mL in 1 AMPULE	INJECTION, SOLUTION	20	27
63323-287-03	Naropin	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	20	27
63323-287-20	Naropin	5 in 1 BOX	INJECTION, SOLUTION	5	27
63323-287-21	Naropin	25 in 1 CARTON	INJECTION, SOLUTION	25	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-287-01	ML - Milliliter	63323-287	80be5fdb-14a8-4c77-9c01-594de5d3b7f9	1	2025-09-12
63323-287-03	ML - Milliliter	63323-287	83c36e76-f361-4ca3-baec-6f331cd89349	1	2019-12-10
63323-287-20	ML - Milliliter	63323-287	5b3e4cf0-0774-4b7d-be1a-b48c82ddfa15	1	2012-07-24
63323-287-21	ML - Milliliter	63323-287	b318f6fc-c33b-46db-ad78-788c40eee524	1	2013-02-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-287	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	27	Current NDC, Legacy NDC, 4 package rows	20240814_23d2d448-a744-4877-9f2d-7e57c198da89.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
63323-287-01	63323028701	20 mL in 1 AMPULE	20 ml					Historical
63323-287-03	63323028703	20 mL in 1 VIAL, SINGLE-DOSE	20 ml					Historical
63323-287-20	63323028720	5 AMPULE in 1 BOX (63323-287-20) / 20 mL in 1 AMPULE (63323-287-01)	5 ampule	2011-05-31	0000-00-00	No	No	Current
63323-287-21	63323028721	25 VIAL, SINGLE-DOSE in 1 CARTON (63323-287-21) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-287-03)		2011-05-31	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

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#