(CHLOROPROCAINE HCI

Product NDC: 51662-1407
Requested package NDC: 51662-1407-1
11-digit product format: 516621407
Labeler code: 51662
Product ID: 51662-1407_101e2af0-c51e-edc4-e063-6394a90a8b8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: (CHLOROPROCAINE HCI
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION; PERINEURAL
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA009435
Marketing category: NDA
Marketing start: 2019-10-13
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: 2026-12-31
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: (CHLOROPROCAINE HCI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLOROPROCAINE HYDROCHLORIDE	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992801	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
94d13f48-fbca-67b4-e053-2995a90a791b	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	SPL version
51662-1407-1	(CHLOROPROCAINE HCI	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	4
51662-1407-2	(CHLOROPROCAINE HCI	1 in 1 POUCH	INJECTION, SOLUTION	1	4
51662-1407-2	(CHLOROPROCAINE HCI	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	4
51662-1407-3	(CHLOROPROCAINE HCI	25 in 1 CASE	INJECTION, SOLUTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1407	(CHLOROPROCAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 4 package rows	20240131_94d13f48-fbca-67b4-e053-2995a90a791b.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 ndc (package): 51662-1407-1 ndc (product): 51662-1407 ndc11 (package): 51662140701
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
992801	chloroprocaine HCl 1 % Injectable Solution	PSN	94d13f48-fbca-67b4-e053-2995a90a791b	4
992801	chloroprocaine hydrochloride 10 MG/ML Injectable Solution	SCD	94d13f48-fbca-67b4-e053-2995a90a791b	4
992801	chloroprocaine hydrochloride 1 % Injectable Solution	SY	94d13f48-fbca-67b4-e053-2995a90a791b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1407-1	51662140701	30 mL in 1 VIAL, MULTI-DOSE (51662-1407-1)	30 ml	2019-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NESACAINE(R) (CHLOROPROCAINE HCI INJECTION, USP) 1% (300mg per 30mL) (10mg per mL) 30mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-29	HUMAN PRESCRIPTION DRUG LABEL	4