Sensorcaine

Product NDC: 0404-9945
11-digit product format: 004049945
Labeler code: 0404
Product ID: 0404-9945_1a2d83ee-c3bc-4957-81a4-c3f020bd81f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Henry Schein, Inc.
Application: NDA018304
Marketing category: NDA
Marketing start: 2022-01-12
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 210 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
2026-08-18 06:07:40	2026-07	N018304-001	SENSORCAINE	0.25%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-002	SENSORCAINE	0.5%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-003	SENSORCAINE	0.75%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-004	SENSORCAINE	0.5%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-005	SENSORCAINE	0.75%;0.0091MG/ML	INJECTABLE / INJECTION	AP	RLD	1983-09-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018304-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-004	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018304-005	AP	1	`caaa826d4ba7…`
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…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1012396	Internal RxNorm lookup
1012455	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
2046d833-2974-42fd-a29e-7fc1dc7166cc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9945-50	Sensorcaine	1 in 1 BAG	INJECTION, SOLUTION	1		6
0404-9945-50	Sensorcaine	50 mL in 1 VIAL	INJECTION, SOLUTION	50		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9945	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240808_2046d833-2974-42fd-a29e-7fc1dc7166cc.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 ndc (product): 0404-9945
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
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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012396	BUPivacaine HCl 0.25 % Injectable Solution	PSN	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012455	Sensorcaine 0.25 % Injectable Solution	PSN	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012455	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Sensorcaine]	SBD	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012396	bupivacaine hydrochloride 2.5 MG/ML Injectable Solution	SCD	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012396	bupivacaine hydrochloride 0.25 % Injectable Solution	SY	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012455	Sensorcaine 0.25 % Injectable Solution	SY	2046d833-2974-42fd-a29e-7fc1dc7166cc	6
1012455	Sensorcaine 2.5 MG/ML Injectable Solution	SY	2046d833-2974-42fd-a29e-7fc1dc7166cc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9945-50	00404994550	1 VIAL in 1 BAG (0404-9945-50) / 50 mL in 1 VIAL	1 vial	2022-01-12	0000-00-00	No	No	Current