Application 070583

Type: ANDA
Sponsor: HOSPIRA

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070583-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP		1987-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070583-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070583-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	1987-02-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A070583-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070583-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070583-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070583-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070583-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070583-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070583-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070583-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070583-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070583-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070583-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070583-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070583-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070583-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070583-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070583-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070583-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070583-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070583-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070583-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070583-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070583-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070583-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070583-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070583-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070583-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070583-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070583-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070583-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070583-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070583-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070583-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070583-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070583-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070583-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070583-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070583-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070583-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070583-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070583-001	AP	1	`e64feba35796…`

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
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Sportpharm LLC	6f9ebeef-350a-495e-a0bf-c335ab48bf1c	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health 107, LLC	8f8f4ece-de78-4c13-8d9f-c3bb7053019d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583 ndc (product): 55154-6970
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	bb44c7e1-d911-4788-908f-09b7b271969b	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583 ndc (product): 0409-1159
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	02a845c3-4521-4926-e397-25ab536e7cf6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583 ndc (product): 0409-1159
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ProPharma Distribution	3f7ab295-6429-4760-e063-6294a90a781f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583
BUPIVICAINE HYDROCHLORIDE	BUPIVICAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	99857946-6084-1bbd-e053-2a95a90af58c	2020-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070583 application number: ANDA070583 ndc (product): 51662-1456

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1159	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
51662-1456	BUPIVICAINE HYDROCHLORIDE	BUPIVICAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1456	BUPIVICAINE HYDROCHLORIDE	BUPIVICAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1456	BUPIVICAINE HYDROCHLORIDE	BUPIVICAINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
55154-6970	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health 107, LLC	ANDA	Current
55154-6970	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-6970	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-6970	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-6970	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
55154-6991	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current