Application 071167

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE	INJECTABLE;INJECTION	0.25%;0.005MG/ML	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
A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION			1988-06-16

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071167-001	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	0.25%;0.005MG/ML	INJECTABLE / INJECTION	1988-06-16	`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 · 1 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): 071167 application number: ANDA071167 ndc (product): 0409-9043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current
0409-9043	Bupivacaine Hydrochloride and Epinephrine	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	Hospira, Inc.	ANDA	Current