NAROPIN

Product NDC: 52584-286
11-digit product format: 525840286
Labeler code: 52584
Product ID: 52584-286_964e7997-ac3a-42a8-98d8-4a9f96979153
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ropivacaine hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: General Injectables & Vaccines, Inc
Application: NDA020533
Marketing category: NDA
Marketing start: 2014-03-11
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-286		D	Discontinued by firm		2026-08-17
excluded package	package	52584-286	52584-286-35	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	52584-286		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-286	52584-286-35	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 14 · 546 observed 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
2026-08-18 06:07:40	2026-07	N020533-001	NAROPIN	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-002	NAROPIN	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-003	NAROPIN	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-004	NAROPIN	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-005	NAROPIN	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-006	NAROPIN	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-007	NAROPIN	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-008	NAROPIN	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-009	NAROPIN	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-010	NAROPIN	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-011	NAROPIN	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD, RS	1996-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020533-001	NAROPIN	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-002	NAROPIN	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-003	NAROPIN	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-004	NAROPIN	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-005	NAROPIN	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-006	NAROPIN	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-007	NAROPIN	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-008	NAROPIN	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-009	NAROPIN	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-010	NAROPIN	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-011	NAROPIN	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD, RS	1996-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-001	NAROPIN	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-002	NAROPIN	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-003	NAROPIN	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-004	NAROPIN	150MG/20ML (7.5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-005	NAROPIN	100MG/10ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-006	NAROPIN	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-007	NAROPIN	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-008	NAROPIN	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-009	NAROPIN	500MG/100ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-010	NAROPIN	1GM/200ML (5MG/ML)	SOLUTION / INJECTION	AP	RLD	2011-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-011	NAROPIN	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	RLD, RS	1996-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020533-001	NAROPIN	20MG/10ML (2MG/ML)	SOLUTION / INJECTION	AP	RLD	1998-05-01	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 12 · 462 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020533-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-007	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-008	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-009	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-010	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-011	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020533-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-007	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-008	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-009	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-010	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-011	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-007	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-008	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-009	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-010	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-011	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020533-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-007	AP	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-006	8162915	2024-05-23	Drug product	2014-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-007	8162915	2024-05-23	Drug product	2014-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-006	8162915	2024-05-23	Drug product	2014-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-007	8162915	2024-05-23	Drug product	2014-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-006	8162915	2024-05-23	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-006	7857802	2026-11-28	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-007	8162915	2024-05-23	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-007	7828787	2025-10-18	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020533-007	7857802	2026-11-28	Drug product	2014-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020533-006	8162915	2024-05-23	Drug product	2014-11-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020533-006	7828787	2025-10-18	Drug product	2014-11-06	`d8e5a09893c0…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ROPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V910P86109	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
ROPIVACAINE	ACTIVE MOIETY	7IO5LYA57N	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52584-286	NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	9	Legacy NDC	20230125_096c2693-8488-48c2-88ee-bf3df95c3f4c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-286-35	52584028635	1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE	2014-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naropin® (ropivacaine HCl Injection, USP) Rx only	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	9