Application 216040

Type: ANDA
Sponsor: MEITHEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.25%	No	No
002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.5%	No	No
003	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	INJECTABLE;INJECTION	0.75%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A216040-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	2023-12-27
A216040-002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	2023-12-27
A216040-003	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	2023-12-27

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 2 · 57 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	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION		2023-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION		2023-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION		2023-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION		2023-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION		2023-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION		2023-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216040-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216040-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216040-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216040-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216040-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216040-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216040-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216040-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216040-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216040-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216040-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216040-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216040-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216040-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216040-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216040-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216040-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216040-001	AP	1	`8072bd15b7f6…`

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 2 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	100201ad-6e4d-4e91-8b5c-621d0bf0dcc2	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc	3c0f567f-b7f8-4ee8-bfb2-61cd82550498	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc	496ccd9e-d1c3-4b5a-93b6-0c457faa1589	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Fosun Pharma USA Inc.	3a996abe-0bb9-4590-e063-6394a90a0b60	2025-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Eugia US LLC	ffecf450-1f01-4721-8e10-251385852612	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Huons Co., Ltd.	2dc693df-3218-4a90-b3f7-21e80966a851	2024-11-20	Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	b6bfc04a-1868-4630-9ca1-8c027af97ce3	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	eb6d8fee-def4-4c96-9972-695e8cea8ea8	2024-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	950d82b6-76a1-0c08-e053-2a95a90a3a92	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPIVACAINE HYDROCHLORIDE generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine hydrochloride	BUPIVACAINE HYDROCHLORIDE	Somerset Therapeutics, LLC	bcaab86f-20f0-4482-8d73-e29b36dced58	2024-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	2024-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8815c8c6-eed8-4afe-a5c1-44d2194025a3	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	4595c642-1869-436c-9550-8f9f255efd27	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	f37a19ad-5e69-44a8-947b-847df2106fb3	2023-08-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	8759cac8-d977-4c2a-814c-5b59f2f0c910	2023-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Marvona SUIK	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	f03f28d9-e42e-404d-9c9c-7707aedb478c	2023-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride	BUPIVACAINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc	fe340f98-a0f3-446e-b281-47fd91c1e537	2023-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupivacaine hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HCl	BUPIVACAINE HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	3335dabe-66d5-440b-a59a-b62993030e0f	2023-06-09	Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine HCl	BUPIVACAINE HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	f29c905e-9a55-446f-a89d-860ad9ade7ad	2023-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	694926ac-aff0-aa1f-e053-2991aa0a9588	2023-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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