Bupivacaine Hydrochloride

Product NDC: 85766-305
Requested package NDC: 85766-305-25
11-digit product format: 857660305
Labeler code: 85766
Product ID: 85766-305_5d7a8f9f-6ff0-efe5-e063-6294a90a0a9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Sportpharm LLC
Application: ANDA207183
Marketing category: ANDA
Marketing start: 2016-05-13
Substance: BUPIVACAINE HYDROCHLORIDE
Active strength: 2.5 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207183-001	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP		2016-05-13
A207183-002	BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP		2016-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207183-001	AP
A207183-002	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 3 · 88 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
2026-10-15 13:18:30	2026-09	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	2016-05-13	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207183-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207183-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207183-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207183-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207183-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207183-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207183-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207183-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207183-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207183-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207183-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207183-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207183-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207183-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207183-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207183-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207183-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207183-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207183-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207183-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207183-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207183-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207183-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207183-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207183-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207183-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207183-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207183-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207183-002	AP	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Bupivacaine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 mg/mL

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	Eugia US LLC	ffecf450-1f01-4721-8e10-251385852612	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	A-S Medication Solutions	1091d4d8-5dad-46e1-8f26-7bc0c5dd833f	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
BUPIVACAINE HCI	BUPIVACAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	e37e1599-db88-2fcd-e053-2995a90a00e5	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
BUPIVACAINE HYDROCHLORIDE injection, solution	BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION	HF Acquisition Co LLC, DBA HealthFirst	06c15208-c600-7173-e063-6394a90a2f94	2024-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	694926ac-aff0-aa1f-e053-2991aa0a9588	2023-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183
Bupivacaine Hydrochloride	BUPIVACAINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	d1642239-4230-b679-e053-2a95a90a3b7c	2023-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207183 application number: ANDA207183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE	73360-54-0	BUPIVACAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-305-25	85766030525	25 VIAL, MULTI-DOSE in 1 CARTON (85766-305-25) / 50 mL in 1 VIAL, MULTI-DOSE	2026-10-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bupivacaine Hydrochloride	Sportpharm LLC \| ASCLEMED USA INC. DBA ENOVACHEM	2026-10-10	HUMAN PRESCRIPTION DRUG LABEL	1