SENSORCAINE

Product NDC: 85766-255
11-digit product format: 857660255
Labeler code: 85766
Product ID: 85766-255_5a564a43-f4dd-1246-e063-6294a90a61fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: PERINEURAL
Labeler: Sportpharm LLC
Application: ANDA070968
Marketing category: ANDA
Marketing start: 2010-11-19
Substance: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 5; .005 mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
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 43.

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
A070968-001	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP		1987-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070968-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070968-001	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A070968-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070968-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070968-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070968-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070968-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070968-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070968-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070968-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070968-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070968-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070968-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070968-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070968-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070968-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070968-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070968-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070968-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070968-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070968-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070968-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070968-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070968-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070968-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070968-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070968-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070968-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070968-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070968-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070968-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070968-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070968-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070968-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070968-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070968-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070968-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070968-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070968-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070968-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070968-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070968-001	AP	1	`f41ea6bd6efb…`

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: SENSORCAINE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	5 mg/mL
EPINEPHRINE BITARTRATE	.005 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7TQO7W3VT8	Internal UNII lookup
30Q7KI53AK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012384	Internal RxNorm lookup
1012417	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
370f3e9f-5081-4b06-9cfb-de39f6bf6ca2	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Sportpharm LLC	370f3e9f-5081-4b06-9cfb-de39f6bf6ca2	2026-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070968 application number: ANDA070968 ndc (product): 85766-255
BUPIVACAINE HCI AND EPINEPHRINE	BUPIVACAINE HCI AND EPINEPHRINE	HF Acquisition Co LLC, DBA HealthFirst	99516811-56e2-9c8a-e053-2a95a90ac9cb	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070968 application number: ANDA070968
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	2023-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070968 application number: ANDA070968

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7TQO7W3VT8	BUPIVACAINE HYDROCHLORIDE	73360-54-0	BUPIVACAINE HYDROCHLORIDE
30Q7KI53AK	EPINEPHRINE BITARTRATE	51-42-3	EPINEPHRINE BITARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85766-255-25	85766025525	25 VIAL, MULTI-DOSE in 1 TRAY (85766-255-25) / 50 mL in 1 VIAL, MULTI-DOSE (85766-255-01)	2026-08-31	No	No	Current