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 1.

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	TE codes	Approval date
A216040-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27
A216040-002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27
A216040-003	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A216040-001	AP
A216040-002	AP
A216040-003	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 2 · 51 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2023-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216040-003	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	2023-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216040-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2023-12-27	`8072bd15b7f6…`

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 1 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	NorthStar RxLLC	ee3b5bbe-4013-4682-b6ee-db86e7788077	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPIVACAINE HYDROCHLORIDE generic name: BUPIVACAINE HYDROCHLORIDE
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	562f4499-f3b7-4d9e-b022-61172176c883	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Marcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Marcaine	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	67578b56-7540-487e-1fba-481255620e78	2026-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Sportpharm LLC	6f9ebeef-350a-495e-a0bf-c335ab48bf1c	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Anthea Pharma Private Limited	4e0cff98-ad0e-494d-8316-b7cdfad6a876	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health 107, LLC	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	bb44c7e1-d911-4788-908f-09b7b271969b	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPIVACAINE HYDROCHLORIDE generic name: BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	0e552e3a-cf52-4d74-9381-6cc1b29b4c90	2026-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUPIVACAINE HYDROCHLORIDE generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	02a845c3-4521-4926-e397-25ab536e7cf6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Sportpharm LLC	0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Marvona-25 SUIK	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	cb71b757-057e-42d4-8a12-8fd8e69a9124	2026-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Brookfield Pharmaceuticals, LLC.	e8b32972-6984-4f1c-e053-2995a90a3277	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ProPharma Distribution	42c973e2-307b-924c-e063-6394a90a737a	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ProPharma Distribution	3f7ab295-6429-4760-e063-6294a90a781f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
bupivacaine hydrochloride	BUPIVACAINE HYDROCHLORIDE	Northstar Rx LLC	adadc041-8d5e-4bf8-a89b-e227729a880d	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bupivacaine hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2046d833-2974-42fd-a29e-7fc1dc7166cc	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ONESOURCE SPECIALTY PHARMA LIMITED	5c10e3a1-7806-40c7-afd2-4c420e141823	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ONESOURCE SPECIALTY PHARMA LIMITED	02d0e5f1-5fab-4420-b673-785fd81d7ae2	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bupivacaine Hydrochloride generic name: BUPIVACAINE HYDROCHLORIDE
Sensorcaine MPF	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	78c6789d-773e-4b26-90bd-34a6b6d730ce	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE HYDROCHLORIDE