ROPIVACAINE HYDROCHLORIDE

Product NDC: 67457-798
11-digit product format: 674570798
Labeler code: 67457
Product ID: 67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ROPIVACAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Mylan Institutional LLC
Application: ANDA206091
Marketing category: ANDA
Marketing start: 2024-03-18
Substance: ROPIVACAINE HYDROCHLORIDE
Active strength: 2 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206091-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP		2023-10-26
A206091-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP		2023-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206091-001	AP
A206091-002	AP

Observed Orange Book product history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206091-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206091-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2023-10-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206091-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206091-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206091-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206091-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206091-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206091-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206091-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206091-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206091-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206091-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206091-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206091-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206091-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206091-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206091-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206091-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206091-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206091-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206091-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206091-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206091-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206091-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206091-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206091-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206091-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206091-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206091-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206091-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206091-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206091-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206091-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206091-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206091-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206091-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206091-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206091-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206091-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206091-002	AP	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206091-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206091-002	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ROPIVACAINE HYDROCHLORIDE	2 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
1734347	Internal RxNorm lookup
1734355	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
9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	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
67457-798-10	ROPIVACAINE HYDROCHLORIDE	100 mL in 1 BAG	INJECTION, SOLUTION	100	1
67457-798-10	ROPIVACAINE HYDROCHLORIDE	1 in 1 POUCH	INJECTION, SOLUTION	1	1
67457-798-98	ROPIVACAINE HYDROCHLORIDE	24 in 1 CARTON	INJECTION, SOLUTION	24	1
67457-798-98	ROPIVACAINE HYDROCHLORIDE	1 in 1 POUCH	INJECTION, SOLUTION	1	1
67457-798-99	ROPIVACAINE HYDROCHLORIDE	10 in 1 CARTON	INJECTION, SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-798-10	ML - Milliliter	67457-798	bfe51cc0-fe4a-4266-9b36-8c315ca2210f	1	2024-04-05
67457-798-99	ML - Milliliter	67457-798	ce666014-4d4e-4667-86f7-ac0686ac8a49	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-798	ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]	1	Current NDC, 5 package rows	20240322_9e1d1b15-c224-4ff4-a39d-3b9cebfc8403.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Mylan Institutional LLC	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206091 application number: ANDA206091 ndc (product): 67457-798

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
1734347	ROPivacaine HCl 0.2 % in 100 ML Injection	PSN	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734355	ROPivacaine HCl 0.2 % in 200 ML Injection	PSN	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734347	100 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734355	200 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734347	ropivacaine HCl 0.2 % per 100 ML Injection	SY	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734355	ropivacaine HCl 0.2 % per 200 ML Injection	SY	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734347	ropivacaine HCl 200 MG per 100 ML Injection	SY	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1
1734355	ropivacaine HCl 400 MG per 200 ML Injection	SY	9e1d1b15-c224-4ff4-a39d-3b9cebfc8403	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67457-798-10	67457079810	100 mL in 1 BAG	100 ml				Historical
67457-798-98	67457079898	24 in 1 CARTON					Historical
67457-798-99	67457079899	10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG	10 pouch	2024-03-18	No	No	Current