Ropivacaine Hydrochloride

Product NDC: 17478-082
11-digit product format: 174780082
Labeler code: 17478
Product ID: 17478-082_32112fae-3aee-4166-affc-595e6c6890cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ropivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; PERINEURAL
Labeler: Akorn
Application: ANDA204636
Marketing category: ANDA
Marketing start: 2018-03-16
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17478-082		I	Inactivated by FDA	2026-10-12
excluded package	package	17478-082	17478-082-90	I	Inactivated by FDA	2026-10-12
excluded package	package	17478-082	17478-082-92	I	Inactivated by FDA	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-082-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-082-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-082-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-082-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-082-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-082-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-082-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-082-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-082-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-082-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-082-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-082-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-082-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-082-92	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-082-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-082-92	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-082-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-082-92	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-082-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-082-92	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-082-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-082-92	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-082-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-082-92	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-082-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-082-92	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-082-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-082-92	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-082-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-082-92	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A204636-001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP		2018-03-16
A204636-002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP		2018-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204636-001	AP
A204636-002	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.

Product history page 1 of 3 · 86 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	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204636-001	ROPIVACAINE HYDROCHLORIDE	200MG/100ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204636-002	ROPIVACAINE HYDROCHLORIDE	400MG/200ML (2MG/ML)	SOLUTION / INJECTION	AP	2018-03-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A204636-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204636-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204636-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204636-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204636-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204636-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204636-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204636-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204636-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204636-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204636-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204636-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204636-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204636-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204636-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204636-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204636-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204636-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204636-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204636-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204636-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204636-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204636-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204636-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204636-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204636-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204636-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204636-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204636-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204636-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204636-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204636-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204636-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A204636-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204636-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A204636-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204636-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204636-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204636-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A204636-002	AP	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
387afa15-cb51-403a-b2e2-1c9d201e07dc	Product name	9	20230426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-082-90	2024-01-30	C162847	48780-1	1030e365-0c9b-111a-e063-dadaa90a10e2	Ropivacaine Hydrochloride Injection USP, 0.2%
17478-082-92	2024-01-30	C162847	48780-1	1030e365-0c9b-111a-e063-dadaa90a10e2	Ropivacaine Hydrochloride Injection USP, 0.2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-082-90	Ropivacaine Hydrochloride	6 in 1 CARTON	INJECTION, SOLUTION	6	7
17478-082-90	Ropivacaine Hydrochloride	100 mL in 1 BOTTLE	INJECTION, SOLUTION	100	7
17478-082-92	Ropivacaine Hydrochloride	6 in 1 CARTON	INJECTION, SOLUTION	6	7
17478-082-92	Ropivacaine Hydrochloride	200 mL in 1 BOTTLE	INJECTION, SOLUTION	200	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-082-90	ML - Milliliter	17478-082	6f96e6e5-80bc-4a4a-982b-159f7d8db3fa	1	2019-02-13
17478-082-92	ML - Milliliter	17478-082	7fc894cd-de27-4f3f-bcd1-514a05dd8f7f	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-082	ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [AKORN]	7	Legacy NDC, 4 package rows	20220916_3f538ea5-1e08-4fb5-9756-696ac3d817a3.zip

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	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734355	ROPivacaine HCl 0.2 % in 200 ML Injection	PSN	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734347	100 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734355	200 ML ropivacaine hydrochloride 2 MG/ML Injection	SCD	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734347	ropivacaine HCl 0.2 % per 100 ML Injection	SY	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734355	ropivacaine HCl 0.2 % per 200 ML Injection	SY	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734347	ropivacaine HCl 200 MG per 100 ML Injection	SY	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7
1734355	ropivacaine HCl 400 MG per 200 ML Injection	SY	3f538ea5-1e08-4fb5-9756-696ac3d817a3	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-082-90	17478008290	6 BOTTLE in 1 CARTON (17478-082-90) > 100 mL in 1 BOTTLE	6 bottle	2018-03-16	0000-00-00	No	No	Current
17478-082-92	17478008292	6 BOTTLE in 1 CARTON (17478-082-92) > 200 mL in 1 BOTTLE	6 bottle	2018-03-16	0000-00-00	No	No	Current