Application 020533

Type: NDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	20MG/10ML (2MG/ML)	Yes	No
002	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	Yes	No
003	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/20ML (5MG/ML)	Yes	No
004	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	Yes	No
005	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	Yes	No
006	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	Yes	No
007	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	Yes	No
008	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	Yes	No
009	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	500MG/100ML (5MG/ML)	Yes	No
010	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	1GM/200ML (5MG/ML)	Yes	No
011	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	Yes	Yes
012	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	75MG/10ML (7.5MG/ML)	No	No
013	NAROPIN	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	50MG/10ML (5MG/ML)	No	No

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…`

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 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 ndc (product): 63323-286
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 ndc (product): 63323-285 ndc (product): 63323-286
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 ndc (product): 63323-288 ndc (product): 63323-285 ndc (product): 63323-287 ndc (product): 63323-286
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 ndc (product): 63323-288 ndc (product): 63323-285 ndc (product): 63323-286
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 ndc (product): 63323-288

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9924	NAROPIN	ropivacaine hydrochloride	Henry Schein, Inc.	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
52584-286	NAROPIN	ropivacaine hydrochloride	General Injectables & Vaccines, Inc	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-285	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-286	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-287	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-288	Naropin	ROPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72129	SUPPL	2022-09-21
71477	SUPPL	2022-06-29
71343	SUPPL	2022-06-16
71335	SUPPL	2022-06-16
57659	ORIG	2019-02-15
56351	SUPPL	2018-11-08
56264	SUPPL	2018-11-05
52705	SUPPL	2018-02-23
2681	SUPPL	2014-10-30
34789	SUPPL	2013-01-07
34790	SUPPL	2012-11-15
34788	SUPPL	2010-02-25
25129	SUPPL	2010-02-25
12691	SUPPL	2010-02-25
2680	SUPPL	2010-02-25
25128	SUPPL	2006-08-11
34787	SUPPL	2006-08-09
12690	SUPPL	2004-08-12
2679	SUPPL	2004-08-12
41417	SUPPL	2004-06-28