NAROPIN

Product NDC: 0404-9924
11-digit product format: 004049924
Labeler code: 0404
Product ID: 0404-9924_47641628-e7ea-4e6b-a214-4a834fcc56be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropivacaine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Henry Schein, Inc.
Application: NDA020533
Marketing category: NDA
Marketing start: 2022-01-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 13 matching rows.

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ROPIVACAINE HYDROCHLORIDE	75MG/10ML (7.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1996-09-24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ROPIVACAINE HYDROCHLORIDE	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1998-05-01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#

Current TE-code rows page 1 of 1 · 11 matching rows.

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#

Current patent rows page 1 of 1 · 2 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N020533-001	NAROPIN	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-002	NAROPIN	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-003	NAROPIN	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-004	NAROPIN	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-005	NAROPIN	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-006	NAROPIN	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-007	NAROPIN	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-008	NAROPIN	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-009	NAROPIN	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-010	NAROPIN	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-011	NAROPIN	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD, RS	1996-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-012	NAROPIN	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-013	NAROPIN	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	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N020533-001	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-002	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-003	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-004	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-005	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-006	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-007	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-008	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-009	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-010	AP	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-011	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N020533-006	7857802	2026-11-28		Drug product	2014-11-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N020533-007	7857802	2026-11-28		Drug product	2014-11-06	`a50c72e98297…`

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAROPIN	ROPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533 ndc (product): 0404-9924
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	cb6583ff-cde4-4280-aa5b-0bea2b844792	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	23d2d448-a744-4877-9f2d-7e57c198da89	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	c6613708-c1f7-4f5c-91a3-ebbc1d7905c6	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533
Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	56dfabf7-f7a8-4601-b17a-cb16fb995b0f	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020533 application number: NDA020533

Additional Listing Data#

Finished product: Yes
Brand name base: NAROPIN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V910P86109	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734475	Internal RxNorm lookup
1734476	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	Available on FDA.report

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	Strength	SPL version
0404-9924-30	NAROPIN	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30		5
0404-9924-30	NAROPIN	1 in 1 BAG	INJECTION, SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9924	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240910_6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02.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
1734476	Naropin 0.5 % in 30 ML Injection	PSN	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734475	ROPivacaine HCl 0.5 % in 30 ML Injection	PSN	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734476	30 ML ropivacaine hydrochloride 5 MG/ML Injection [Naropin]	SBD	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734475	30 ML ropivacaine hydrochloride 5 MG/ML Injection	SCD	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734476	30 ML Naropin 5 MG/ML Injection	SY	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734476	Naropin 0.5 % per 30 ML Injection	SY	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734476	Naropin 150 MG per 30 ML Injection	SY	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734475	ropivacaine HCl 0.5 % per 30 ML Injection	SY	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5
1734475	ropivacaine HCl 150 MG per 30 ML Injection	SY	6a2f1f6d-026f-4f39-aee0-5b75b8eb5c02	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9924-30	00404992430	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9924-30) / 30 mL in 1 VIAL, SINGLE-DOSE	2022-01-13	0000-00-00	No	No	Current