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ROPIVACAINE HYDROCHLORIDE	75MG/10ML (7.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1996-09-24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ROPIVACAINE HYDROCHLORIDE	50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / INJECTION		RLD	1998-05-01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

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
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

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