Ropivacaine Hydrochloride

Product NDC: 72485-519
11-digit product format: 724850519
Labeler code: 72485
Product ID: 72485-519_3a56f3c1-048a-4c4e-954a-94d8cd04985a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropivacaine Hydrochloride
Dosage form: INJECTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA212808
Marketing category: ANDA
Marketing start: 2026-06-01
Substance: ROPIVACAINE HYDROCHLORIDE
Active strength: 150 mg/30mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212808-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09
A212808-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09
A212808-003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09
A212808-004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09
A212808-005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23
A212808-006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A212808-001	AP
A212808-002	AP
A212808-003	AP
A212808-004	AP
A212808-005	AP
A212808-006	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.

Product history page 1 of 5 · 188 observed 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
2026-09-14 22:38:34	2026-08	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-005	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-006	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2024-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-001	ROPIVACAINE HYDROCHLORIDE	40MG/20ML (2MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-002	ROPIVACAINE HYDROCHLORIDE	100MG/20ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-003	ROPIVACAINE HYDROCHLORIDE	150MG/30ML (5MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-004	ROPIVACAINE HYDROCHLORIDE	200MG/20ML (10MG/ML)	SOLUTION / INJECTION	AP	2020-04-09	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 188 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212808-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-004	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-005	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212808-006	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212808-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-005	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212808-006	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212808-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-005	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212808-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-005	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212808-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212808-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-005	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212808-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-005	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212808-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212808-004	AP	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	150 mg/30mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1734475	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
3849f5ce-d077-4318-935d-294be6948142	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

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
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Armas Pharmaceuticals Inc.	3849f5ce-d077-4318-935d-294be6948142	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808 ndc (product): 72485-519
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLA Pharmaceuticals, LLC	5b3c642b-ab31-45fd-ac0b-b9f6e6cfe3a9	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	FRESENIUS KABI USA, LLC	da4a7675-97bf-4d2a-9fdc-c1b4b2999126	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Caplin Steriles Limited	a9010ea8-0923-44e4-a7c7-7d65d37d06db	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808
Ropivacaine Hydrochloride	ROPIVACAINE HYDROCHLORIDE	Civica, Inc.	1fb8e90a-4141-4707-8be6-31f2da5c8fd5	2024-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808
ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	Baxter Healthcare Corporation	781d4b7f-7556-4695-8d48-7772d7a0d8e9	2023-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212808 application number: ANDA212808

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72485-519-10	72485051910	10 VIAL, SINGLE-DOSE in 1 CARTON (72485-519-10) / 30 mL in 1 VIAL, SINGLE-DOSE (72485-519-01)	2026-06-01	No	No	Current