SENSORCAINE

Product NDC: 63323-462
11-digit product format: 633230462
Labeler code: 63323
Product ID: 63323-462_13a48007-3784-46f2-bd4d-da1004186b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA018304
Marketing category: NDA
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: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018304-001	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-002	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-003	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N018304-004	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02
N018304-005	SENSORCAINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N018304-001	AP
N018304-002	AP
N018304-003	AP
N018304-004	AP
N018304-005	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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N018304-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018304-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018304-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018304-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018304-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018304-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018304-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018304-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018304-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018304-005	AP	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1672917	Internal RxNorm lookup
1672919	Internal RxNorm lookup
1673296	Internal RxNorm lookup
1673298	Internal RxNorm lookup
1724880	Internal RxNorm lookup
1724881	Internal RxNorm lookup
1724884	Internal RxNorm lookup
1724885	Internal RxNorm lookup
1725078	Internal RxNorm lookup
1725082	Internal RxNorm lookup
1725175	Internal RxNorm lookup
1725177	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
dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	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	SPL version
63323-462-01	SENSORCAINEMPF	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	10
63323-462-02	SENSORCAINEMPF	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	10
63323-462-04	SENSORCAINEMPF	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	10
63323-462-17	SENSORCAINEMPF	25 in 1 TRAY	INJECTION, SOLUTION	25	10
63323-462-31	SENSORCAINEMPF	5 in 1 BOX	INJECTION, SOLUTION	5	10
63323-462-37	SENSORCAINEMPF	25 in 1 TRAY	INJECTION, SOLUTION	25	10
63323-462-03	SENSORCAINEMPF	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	1
63323-462-38	SENSORCAINEMPF	25 in 1 TRAY	INJECTION, SOLUTION	25	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-462-01	ML - Milliliter	63323-462	1b92033e-d9a3-49e0-a188-d3d6a6870b65	1	2021-06-02
63323-462-03	ML - Milliliter	63323-462	131a845b-210c-4565-b1ba-3afc2e226992	1	2024-11-05
63323-462-04	ML - Milliliter	63323-462	6222f437-7bba-482c-b18c-90f34f3c4aa0	1	2020-03-10
63323-462-17	ML - Milliliter	63323-462	a5c42b08-909e-402c-bcaa-ee1032410b09	1	2012-07-24
63323-462-31	ML - Milliliter	63323-462	e635c953-6018-4f14-a690-c954caa7a9ba	1	2012-07-24
63323-462-37	ML - Milliliter	63323-462	65d27d34-28f5-4540-8242-8bde8ac0c7ea	1	2012-07-24
63323-462-38	ML - Milliliter	63323-462	ede728e0-bd7a-47b4-99d7-6df4e8c38ccb	1	2024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPIVACAINE HYDROCHLORIDE	ACTIVE INGREDIENT	7TQO7W3VT8	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
EPINEPHRINE BITARTRATE	ACTIVE INGREDIENT	30Q7KI53AK	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
EPINEPHRINE	ACTIVE MOIETY	YKH834O4BH	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-462	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	10	Current NDC, Legacy NDC, 6 package rows	20241031_eb6d8fee-def4-4c96-9972-695e8cea8ea8.zip
63323-462	SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION SENSORCAINE MPF (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20241012_dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BUPIVACAINE HCl	BUPIVACAINE HCL	HF Acquisition Co LLC, DBA HealthFirst	e391f807-7699-6d82-e053-2a95a90ab641	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	2046d833-2974-42fd-a29e-7fc1dc7166cc	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304
Sensorcaine	BUPIVACAINE HYDROCHLORIDE	Henry Schein, Inc.	100201ad-6e4d-4e91-8b5c-621d0bf0dcc2	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	eb6d8fee-def4-4c96-9972-695e8cea8ea8	2024-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 63323-462
SENSORCAINE MPF	BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	Fresenius Kabi USA, LLC	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	2022-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018304 application number: NDA018304 ndc (product): 63323-462

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
1725078	BUPivacaine HCl 0.25 % in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012396	BUPivacaine HCl 0.25 % Injectable Solution	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672917	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672919	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724884	BUPivacaine HCl 0.5 % in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012404	BUPivacaine HCl 0.5 % Injectable Solution	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012391	BUPivacaine HCl 0.75 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725175	Sensorcaine 0.25 % in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725177	Sensorcaine 0.25 % in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012455	Sensorcaine 0.25 % Injectable Solution	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673298	Sensorcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724881	Sensorcaine 0.5 % in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724885	Sensorcaine 0.5 % in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012457	Sensorcaine 0.5 % Injectable Solution	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012421	Sensorcaine 0.75 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673296	Sensorcaine 5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725175	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673296	10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724881	10 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725177	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673298	30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724885	30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012421	30 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012455	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012457	bupivacaine hydrochloride 5 MG/ML Injectable Solution [Sensorcaine]	SBD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672917	10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724880	10 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725082	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672919	30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724884	30 ML bupivacaine hydrochloride 5 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012391	30 ML bupivacaine hydrochloride 7.5 MG/ML / epinephrine 0.005 MG/ML Injection	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012396	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012404	bupivacaine hydrochloride 5 MG/ML Injectable Solution	SCD	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725175	10 ML Sensorcaine 2.5 MG/ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724881	10 ML Sensorcaine 5 MG/ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725177	30 ML Sensorcaine 2.5 MG/ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724885	30 ML Sensorcaine 5 MG/ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725078	bupivacaine HCl 0.25 % in 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725082	bupivacaine HCl 0.25 % per 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672917	bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1672919	bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724880	bupivacaine HCl 0.5 % in 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724884	bupivacaine HCl 0.5 % in 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012391	bupivacaine HCl 0.75 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012396	bupivacaine hydrochloride 0.25 % Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012404	bupivacaine hydrochloride 0.5 % Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012455	Sensorcaine 0.25 % Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673298	Sensorcaine 0.5 % / epinephrine (as bitratrate) 1:200,000 in 30 mL Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012457	Sensorcaine 0.5 % Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012455	Sensorcaine 2.5 MG/ML Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1673296	Sensorcaine 5 % / EPINEPHrine 1:200,000 per 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012457	Sensorcaine 5 MG/ML Injectable Solution	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012421	Sensorcaine with Epinephrine 0.75 % / 1:200,000 (bupivacaine hydrochloride / epinephrine (as epinephrine bitartrate) ) per 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725175	Sensorcaine-MPF 0.25 % in 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725177	Sensorcaine-MPF 0.25 % in 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724881	Sensorcaine-MPF 0.5 % in 10 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1724885	Sensorcaine-MPF 0.5 % in 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1012421	Sensorcaine-MPF 0.75 % / epinephrine 1:200,000 per 30 ML Injection	SY	eb6d8fee-def4-4c96-9972-695e8cea8ea8	10
1725078	BUPivacaine HCl 0.25 % in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725082	BUPivacaine HCl 0.25 % in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1672917	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1672919	BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724880	BUPivacaine HCl 0.5 % in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724884	BUPivacaine HCl 0.5 % in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725175	Sensorcaine 0.25 % in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725177	Sensorcaine 0.25 % in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1673298	Sensorcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724881	Sensorcaine 0.5 % in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724885	Sensorcaine 0.5 % in 30 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1673296	Sensorcaine 5 % / EPINEPHrine 1:200,000 in 10 ML Injection	PSN	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725175	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1673296	10 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724881	10 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725177	30 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Sensorcaine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1673298	30 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Sensorcaine with Epinephrine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1724885	30 ML bupivacaine hydrochloride 5 MG/ML Injection [Sensorcaine]	SBD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1
1725078	10 ML bupivacaine hydrochloride 2.5 MG/ML Injection	SCD	dcf3c0ad-9eb8-4ee7-96df-d0db7ff23175	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-462-01	63323046201	30 mL in 1 VIAL, SINGLE-DOSE	30 ml					Historical
63323-462-02	63323046202	30 mL in 1 VIAL, SINGLE-DOSE	30 ml					Historical
63323-462-03	63323046203	30 mL in 1 VIAL, SINGLE-DOSE	30 ml					Historical
63323-462-04	63323046204	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
63323-462-17	63323046217	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-462-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-462-04)		2010-11-19	0000-00-00	No	No	Current
63323-462-31	63323046231	5 VIAL, SINGLE-DOSE in 1 BOX (63323-462-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-462-02)		2010-11-19	0000-00-00	No	No	Current
63323-462-37	63323046237	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-462-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-462-01)		2010-11-19	0000-00-00	No	No	Current
63323-462-38	63323046238	25 VIAL, SINGLE-DOSE in 1 TRAY (63323-462-38) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-462-03)		2022-07-29		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SENSORCAINE	Fresenius Kabi USA, LLC	2024-10-15	HUMAN PRESCRIPTION DRUG LABEL	10
SENSORCAINE MPF	Fresenius Kabi USA, LLC	2022-08-17	HUMAN PRESCRIPTION DRUG LABEL	1
SENSORCAINE MPF	REMEDYREPACK INC.	2021-09-20	HUMAN PRESCRIPTION DRUG LABEL	2