Sensorcaine

Product NDC: 52584-465
11-digit product format: 525840465
Labeler code: 52584
Product ID: 52584-465_3bea6afe-dc78-4db1-9a10-5d454c5ac335
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bupivacaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: General Injectables & Vaccines, Inc
Application: NDA018304
Marketing category: NDA
Marketing start: 2011-10-17
Marketing end: 2026-01-31
Substance: BUPIVACAINE HYDROCHLORIDE
Active strength: 3 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52584-465		D	Discontinued by firm		2026-08-11
excluded package	package	52584-465	52584-465-57	D	Discontinued by firm		2026-08-11

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Bupivacaine Hydrochloride	ACTIVE INGREDIENT	7TQO7W3VT8	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Bupivacaine	ACTIVE MOIETY	Y8335394RO	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52584-465	SENSORCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	10	Legacy NDC	20221230_e5808712-4487-43b2-891f-e1ef47a9e28d.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-465-57	52584046557	1 VIAL in 1 BAG (52584-465-57) > 50 mL in 1 VIAL	1 vial	2011-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sensorcaine 0.25% (Bupivacaine HCl) 50mL	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	10