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

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ROPIVACAINE HYDROCHLORIDE	75MG/10ML (7.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1996-09-24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ROPIVACAINE HYDROCHLORIDE	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1998-05-01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

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 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 2 · 22 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905189	Internal RxNorm lookup
905191	Internal RxNorm lookup
1734084	Internal RxNorm lookup
1734086	Internal RxNorm lookup
1734090	Internal RxNorm lookup
1734091	Internal RxNorm lookup
1734203	Internal RxNorm lookup
1734204	Internal RxNorm lookup
1734207	Internal RxNorm lookup
1734208	Internal RxNorm lookup
1734347	Internal RxNorm lookup
1734348	Internal RxNorm lookup
1734355	Internal RxNorm lookup
1734356	Internal RxNorm lookup
1734475	Internal RxNorm lookup
1734476	Internal RxNorm lookup
1734479	Internal RxNorm lookup
1734480	Internal RxNorm lookup
1734481	Internal RxNorm lookup
1734482	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
23d2d448-a744-4877-9f2d-7e57c198da89	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	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

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 ndc (product): 63323-287
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

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