Nesacaine

Product NDC: 63323-476
Requested package NDC: 63323-476-37
11-digit product format: 633230476
Labeler code: 63323
Product ID: 63323-476_46570679-3557-4250-bb21-b406097e106d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLOROPROCAINE HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: Fresenius Kabi USA, LLC
Application: NDA009435
Marketing category: NDA
Marketing start: 2010-10-14
Substance: CHLOROPROCAINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 258 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
2026-09-14 22:38:34	2026-08	N009435-001	NESACAINE	1%	INJECTABLE / INJECTION		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-002	NESACAINE	2%	INJECTABLE / INJECTION	AP	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-003	NESACAINE-MPF	2%	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-004	NESACAINE-MPF	3%	INJECTABLE / INJECTION		Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-006	NESACAINE-MPF	2%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-007	NESACAINE-MPF	3%	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-02	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N009435-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-006	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009435-007	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nesacaine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOROPROCAINE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LT7Z1YW11H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992801	Internal RxNorm lookup
992803	Internal RxNorm lookup
992805	Internal RxNorm lookup
992807	Internal RxNorm lookup
992809	Internal RxNorm lookup
992811	Internal RxNorm lookup
1794184	Internal RxNorm lookup
1794186	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
a844e68a-1462-40e4-be5e-f56214906eb9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
5d35ea28-18de-4c43-8b81-d4140e17b91a	Product name	1	20230912
9f0ed4af-e581-4924-816e-213668654c3d	Product name	1	20171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63323-476-01	Nesacaine	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30		6
63323-476-37	Nesacaine	25 in 1 TRAY	INJECTION, SOLUTION	25		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-476-01	ML - Milliliter	63323-476	05f34fac-bdcc-487a-b800-aab5627fe90d	1	2022-03-09
63323-476-37	ML - Milliliter	63323-476	59caad09-c495-453a-b9ae-d42aeb5d3bdf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOROPROCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	LT7Z1YW11H	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
CHLOROPROCAINE	ACTIVE MOIETY	5YVB0POT2H	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	3
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
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NESACAINE (CHLOROPROCAINE 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
63323-476	NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20220914_a844e68a-1462-40e4-be5e-f56214906eb9.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 · 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 ndc (package): 63323-476-37 ndc (product): 63323-476 ndc11 (package): 63323047637

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992801	chloroprocaine HCl 1 % Injectable Solution	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794184	chloroprocaine HCl 2 % in 20 ML Injection	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
992805	chloroprocaine HCl 2 % Injectable Solution	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
992809	chloroprocaine HCl 3 % in 20 ML Injection	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
992803	Nesacaine 1 % Injectable Solution	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794186	Nesacaine 2 % in 20 ML Injection	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
992807	Nesacaine 2 % Injectable Solution	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
992811	Nesacaine 3 % in 20 ML Injection	PSN	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794186	20 ML chloroprocaine hydrochloride 20 MG/ML Injection [Nesacaine]	SBD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992811	20 ML chloroprocaine hydrochloride 30 MG/ML Injection [Nesacaine]	SBD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992803	chloroprocaine hydrochloride 10 MG/ML Injectable Solution [Nesacaine]	SBD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992807	chloroprocaine hydrochloride 20 MG/ML Injectable Solution [Nesacaine]	SBD	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794184	20 ML chloroprocaine hydrochloride 20 MG/ML Injection	SCD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992809	20 ML chloroprocaine hydrochloride 30 MG/ML Injection	SCD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992801	chloroprocaine hydrochloride 10 MG/ML Injectable Solution	SCD	a844e68a-1462-40e4-be5e-f56214906eb9	6
992805	chloroprocaine hydrochloride 20 MG/ML Injectable Solution	SCD	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794186	20 ML Nesacaine 20 MG/ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992811	20 ML Nesacaine 30 MG/ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992801	chloroprocaine hydrochloride 1 % Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992805	chloroprocaine hydrochloride 2 % Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794184	chloroprocaine hydrochloride 2 % per 20 ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992809	chloroprocaine hydrochloride 3 % per 20 ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992803	Nesacaine 1 % Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992803	Nesacaine 10 MG/ML Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992807	Nesacaine 2 % Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
1794186	Nesacaine 2 % per 20 ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992807	Nesacaine 20 MG/ML Injectable Solution	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992811	Nesacaine 3 % per 20 ML Injection	SY	a844e68a-1462-40e4-be5e-f56214906eb9	6
992805	chloroprocaine HCl 2 % Injectable Solution	PSN	94d13f48-fbc6-67b4-e053-2995a90a791b	4
992805	chloroprocaine hydrochloride 20 MG/ML Injectable Solution	SCD	94d13f48-fbc6-67b4-e053-2995a90a791b	4
992805	chloroprocaine hydrochloride 2 % Injectable Solution	SY	94d13f48-fbc6-67b4-e053-2995a90a791b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-476-37	63323047637	25 VIAL, MULTI-DOSE in 1 TRAY (63323-476-37) / 30 mL in 1 VIAL, MULTI-DOSE (63323-476-01)	2010-10-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NESACAINE	Henry Schein, Inc.	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	6
NESACAINE(R) (CHLOROPROCAINE HCI INJECTION, USP) 2% (600mg per 30mL) (20mg per mL) 30mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-22	HUMAN PRESCRIPTION DRUG LABEL	4
NESACAINE	General Injectables & Vaccines, Inc	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	10
Nesacaine ® (chloroprocaine HCl Injection, USP) Nesacaine ® -MPF (chloroprocaine HCl Injection, USP)	Fresenius Kabi USA, LLC	2022-09-01	HUMAN PRESCRIPTION DRUG LABEL	6