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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020533-001	NAROPIN	ROPIVACAINE HYDROCHLORIDE	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01
N020533-002	NAROPIN	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-003	NAROPIN	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01
N020533-004	NAROPIN	ROPIVACAINE HYDROCHLORIDE	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-005	NAROPIN	ROPIVACAINE HYDROCHLORIDE	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-006	NAROPIN	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-007	NAROPIN	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-008	NAROPIN	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24
N020533-009	NAROPIN	ROPIVACAINE HYDROCHLORIDE	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04
N020533-010	NAROPIN	ROPIVACAINE HYDROCHLORIDE	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04
N020533-011	NAROPIN	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD, RS	1996-09-24
N020533-012	NAROPIN	ROPIVACAINE HYDROCHLORIDE	75MG/10ML (7.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1996-09-24
N020533-013	NAROPIN	ROPIVACAINE HYDROCHLORIDE	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1998-05-01

Therapeutic equivalence codes#

Application-product, TE code table
Application-product	TE code
N020533-001	AP
N020533-002	AP
N020533-003	AP
N020533-004	AP
N020533-005	AP
N020533-006	AP
N020533-007	AP
N020533-008	AP
N020533-009	AP
N020533-010	AP
N020533-011	AP

Orange Book patents#

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N020533-006	7857802	2026-11-28		Drug product	2014-11-06
N020533-007	7857802	2026-11-28		Drug product	2014-11-06

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	23d2d448-a744-4877-9f2d-7e57c198da89	2024-08-06	Warnings, Adverse reactions	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Delay in proper management of dose-related toxicity, underventilation, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. ( 5.1 ) In performing NAROPIN blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardia arrest. ( 5.2 ) Intra-articular infusions of local anesthetics may cause chondrolysis. NAROPIN is not approved for this use. ( 5.3 ). Signs of methemoglobinemia may occur. ( 5.4 ) 5.1 General Warnings and Precautions Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an IV line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies [see Adverse Reactions ( 6 ) and Overdosage ( 10.1 )]. Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use [see Adverse Reactions ( 6 )] . The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxici...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to NAROPIN at concentrations up to 1% in clinical trials. Each patient was counted once for each type of adverse event. Because clinical trials are conducted under widely conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Incidence ≥ 5% For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥ 5% in all clinical studies (N=3988): hypotension (37%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5%). Incidence 1 to 5% Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials The reported adverse events are derived from controlled clinical studies with NAROPIN (concentrations ranged from 0.125% to 1% for NAROPIN and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Table 2 and Table 3 list adverse events (number and percentage) that occurred in at least 1% of NAROPIN-treated patients in these studies. The majority of patients receiving concentrations higher than 5 mg/mL (0.5%) were treated with NAROPIN. Table 2 Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Postoperative Pain Management, Peripheral Ner...

adverse reactions table

Table 2 Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Postoperative Pain Management, Peripheral Nerve Block and Local Infiltration) NAROPIN total N=1661Bupivacaine total N=1433Adverse ReactionN%N%Hypotension 536 (32.3) 408 (28.5) Nausea 283 (17) 207 (14.4) Vomiting 117 (7) 88 (6.1) Bradycardia 96 (5.8) 73 (5.1) Headache 84 (5.1) 68 (4.7) Paresthesia 82 (4.9) 57 (4) Back pain 73 (4.4) 75 (5.2) Pain 71 (4.3) 71 (5) Pruritus 63 (3.8) 40 (2.8) Fever 61 (3.7) 37 (2.6) Dizziness 42 (2.5) 23 (1.6) Rigors (Chills) 42 (2.5) 24 (1.7) Postoperative complications 41 (2.5) 44 (3.1) Hypoesthesia 27 (1.6) 24 (1.7) Urinary retention 23 (1.4) 20 (1.4) Progression of labor poor/failed 23 (1.4) 22 (1.5) Anxiety 21 (1.3) 11 (0.8) Breast disorder, breast-feeding 21 (1.3) 12 (0.8) Rhinitis 18 (1.1) 13 (0.9)

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
ROPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V910P86109	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	4
ROPIVACAINE	ACTIVE MOIETY	7IO5LYA57N	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]	4

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® (ropivacaine HCl) Injection	APP Pharmaceuticals, LLC \| Fresenius Kabi Norge AS	2011-09-15	HUMAN PRESCRIPTION DRUG LABEL	4