SENSORCAINE

Product NDC: 63323-461
Requested package NDC: 63323-461-57
11-digit product format: 633230461
Labeler code: 63323
Product ID: 63323-461_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: ANDA070967
Marketing category: ANDA
Marketing start: 2010-11-19
Substance: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength: 2.5; .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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63323-461	63323-461-57	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A070967-001	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.25%;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
A070967-001	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	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070967-001	SENSORCAINE	0.25%;0.0091MG/ML	INJECTABLE / INJECTION	AP	1987-10-13	`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	A070967-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070967-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070967-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070967-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070967-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070967-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070967-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070967-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070967-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070967-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070967-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070967-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070967-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070967-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070967-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070967-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070967-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070967-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070967-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070967-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070967-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070967-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070967-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070967-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070967-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070967-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070967-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070967-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070967-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070967-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070967-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070967-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070967-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070967-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070967-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070967-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070967-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070967-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070967-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070967-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: SENSORCAINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPIVACAINE HYDROCHLORIDE	2.5 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012377	Internal RxNorm lookup
1012384	Internal RxNorm lookup
1012413	Internal RxNorm lookup
1012417	Internal RxNorm lookup
1724786	Internal RxNorm lookup
1724787	Internal RxNorm lookup
1724809	Internal RxNorm lookup
1724810	Internal RxNorm lookup
1867594	Internal RxNorm lookup
1867596	Internal RxNorm lookup
1867618	Internal RxNorm lookup
1867620	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
bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0b4ec9ca-d305-43fc-88dd-7a510313efe0	Product name	1	20260105
bb209f42-a85f-4fee-9d3d-c9dded168625	Product name	1	20251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3	Product name	3	20251118
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
b5b1095b-40cd-8a9e-b111-502545045b07	Product name	4	20250325
e190029e-423b-473c-8e04-2ada59b5b711	Product name	1	20250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
e0031c74-3853-42bc-8e10-86dbbe83992e	Product name	2	20231116
f7046b89-2016-499a-adc6-78479172abc6	Product name	1	20230425
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
2686d634-e712-4007-8dbf-3d37c6c4d71f	Product name	1	20181121
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42	Product name	1	20180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303a	Product name	1	20170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-461-01	SENSORCAINE	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50		7
63323-461-57	SENSORCAINE	25 in 1 TRAY	INJECTION, SOLUTION	25		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-461-01	ML - Milliliter	63323-461	57ba37a9-3a24-42da-a55f-443914af5259	1	2021-06-02
63323-461-57	ML - Milliliter	63323-461	832b75a3-bb7e-4cd3-a1a3-1d99f175d18e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-461	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 2 package rows	20230712_bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)	SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	946ce625-3647-5083-e053-2a95a90a1ebc	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070967 application number: ANDA070967
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): 070967 application number: ANDA070967 ndc (package): 63323-461-57 ndc (product): 63323-461 ndc11 (package): 63323046157

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1867594	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867596	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012377	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012384	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724787	BUPivacaine HCl 0.75 % in 10 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724786	BUPivacaine HCl 0.75 % in 30 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867618	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867620	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012413	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012417	Sensorcaine 0.5 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724809	Sensorcaine 0.75 % in 10 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724810	Sensorcaine 0.75 % in 30 ML Injection	PSN	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867618	10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724809	10 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Sensorcaine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867620	30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724810	30 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Sensorcaine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012413	bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Sensorcaine with Epinephrine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012417	bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Sensorcaine with Epinephrine]	SBD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867594	10 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724787	10 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867596	30 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724786	30 ML bupivacaine hydrochloride 7.5 MG/ML Injection	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012377	bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012384	bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution	SCD	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724809	10 ML Sensorcaine 7.5 MG/ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724810	30 ML Sensorcaine 7.5 MG/ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867594	bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867596	bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724787	bupivacaine HCl 0.75 % in 10 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724786	bupivacaine HCl 0.75 % in 30 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724786	bupivacaine HCl 225 MG per 30 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724787	bupivacaine HCl 75 MG per 10 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012377	bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012384	bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012413	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867618	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 per 10 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1867620	Sensorcaine 0.25 % / EPINEPHrine 1:200,000 per 30 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012413	Sensorcaine with Epinephrine 0.25/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012417	Sensorcaine with Epinephrine 0.5/1:200000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012417	Sensorcaine-MPF 0.5 % / epinephrine 1:200,000 Injectable Solution	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724809	Sensorcaine-MPF 0.75 % in 10 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1724810	Sensorcaine-MPF 0.75 % in 30 ML Injection	SY	bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb	7
1012377	BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable Solution	PSN	946ce625-3647-5083-e053-2a95a90a1ebc	4
1012377	bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution	SCD	946ce625-3647-5083-e053-2a95a90a1ebc	4
1012377	bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable Solution	SY	946ce625-3647-5083-e053-2a95a90a1ebc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-461-57	63323046157	25 VIAL, MULTI-DOSE in 1 TRAY (63323-461-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-461-01)	2010-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	4
SENSORCAINE MPF	Fresenius Kabi USA, LLC	2023-04-30	HUMAN PRESCRIPTION DRUG LABEL	7