Home NDC 63323-476 Nesacaine
Product NDC 63323-476
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 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 · 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.
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.
Additional Listing Data#
Finished product Yes
Brand name base Nesacaine
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 (product): 63323-476
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-476-01 63323047601 30 mL in 1 VIAL, MULTI-DOSE 30 ml Historical 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