Nesacaine

Product NDC: 52584-475
11-digit product format: 525840475
Labeler code: 52584
Product ID: 52584-475_a6c9dfd2-eede-4b96-b231-392059befa92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chloroprocaine Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: General Injectables & Vaccines, Inc
Application: NDA009435
Marketing category: NDA
Marketing start: 2011-10-03
Marketing end: 2023-08-31
Substance: CHLOROPROCAINE HYDROCHLORIDE
Active strength: 10 mg/mL
Pharmacologic classes: Ester Local Anesthetic [EPC], Esters [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	52584-475		D	Discontinued by firm		2026-08-17
excluded package	package	52584-475	52584-475-37	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52584-475-37	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52584-475-37	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52584-475-37	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52584-475-37	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52584-475-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52584-475-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52584-475-37	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52584-475-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52584-475-37	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52584-475-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52584-475-37	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52584-475-37	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N009435-001	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982
N009435-002	NESACAINE	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982
N009435-003	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION		Approved before 1982
N009435-004	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION		Approved before 1982
N009435-006	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02
N009435-007	NESACAINE-MPF	CHLOROPROCAINE HYDROCHLORIDE	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N009435-002	AP
N009435-006	AP
N009435-007	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 7 · 252 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	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N009435-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-006	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009435-007	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009435-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-006	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009435-007	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-006	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009435-007	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009435-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-006	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009435-007	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-006	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009435-007	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-006	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009435-007	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-006	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009435-007	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-006	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009435-007	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-006	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009435-007	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-006	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009435-007	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009435-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009435-006	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009435-007	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-006	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009435-007	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-006	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009435-007	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N009435-002	AP	1	`1e350fbaab3a…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Chloroprocaine Hydrochloride	ACTIVE INGREDIENT	LT7Z1YW11H	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Chloroprocaine	ACTIVE MOIETY	5YVB0POT2H	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
(CHLOROPROCAINE HCI	(CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	94d13f48-fbca-67b4-e053-2995a90a791b	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435
CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	9611d194-b6dd-93f4-e053-2a95a90a1816	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435
CHLOROPROCAINE HCI	CHLOROPROCAINE HCI	HF Acquisition Co LLC, DBA HealthFirst	94d13f48-fbc6-67b4-e053-2995a90a791b	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435
Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a844e68a-1462-40e4-be5e-f56214906eb9	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 009435 application number: NDA009435

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LT7Z1YW11H	CHLOROPROCAINE HYDROCHLORIDE	3858-89-7	CHLOROPROCAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-475-37	52584047537	1 VIAL in 1 BAG (52584-475-37) > 30 mL in 1 VIAL	1 vial	2011-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nesacaine 1% 10mg/mL 30mL Multiple Dose Vial	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	9