Application 070584

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	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A070584-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		1986-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070584-001	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 · 41 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	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070584-001	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	1986-02-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A070584-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070584-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070584-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070584-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070584-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070584-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070584-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070584-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070584-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070584-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070584-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070584-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070584-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070584-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070584-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070584-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070584-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070584-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070584-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070584-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070584-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070584-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070584-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070584-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070584-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070584-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070584-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070584-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070584-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070584-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070584-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070584-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070584-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070584-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070584-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070584-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070584-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070584-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070584-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070584-001	AP	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	02a845c3-4521-4926-e397-25ab536e7cf6	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070584 application number: ANDA070584 ndc (product): 0409-1162
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Sportpharm LLC	0e6a55f0-5107-4ea9-9ee1-5c6c09bbe4a6	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070584 application number: ANDA070584
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	ProPharma Distribution	42c973e2-307b-924c-e063-6394a90a737a	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070584 application number: ANDA070584
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Asclemed USA, Inc.	8759cac8-d977-4c2a-814c-5b59f2f0c910	2023-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070584 application number: ANDA070584

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-1162	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
55154-4736	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Cardinal Health	ANDA	Current
70518-2040	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2040	Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current