FDA.reportPublic FDA data

Nesacaine

Product NDC
63323-477
11-digit product format
633230477
Labeler code
63323
Product ID
63323-477_46570679-3557-4250-bb21-b406097e106d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLOROPROCAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; 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

Additional Listing Data#

Finished product
Yes
Brand name base
Nesacaine
Brand name suffix
MPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLT7Z1YW11H
Rxcui992801, 992803, 992805, 992807, 992809, 992811, 1794184, 1794186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5d35ea28-18de-4c43-8b81-d4140e17b91aProduct name120230912
9f0ed4af-e581-4924-816e-213668654c3dProduct name120171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-477-01NesacaineMPF20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION206
63323-477-27NesacaineMPF25 in 1 TRAYINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-477-01ML - Milliliter63323-47775524983-3194-46ea-a9eb-0956b4f1f8ce12021-02-05
63323-477-27ML - Milliliter63323-477c191d4c5-bda8-4adc-9b95-f37b3b8df70512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOROPROCAINE HYDROCHLORIDEACTIVE INGREDIENTLT7Z1YW11HNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
CHLOROPROCAINEACTIVE MOIETY5YVB0POT2HNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-477NESACAINE (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION NESACAINE MPF (CHLOROPROCAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20220914_a844e68a-1462-40e4-be5e-f56214906eb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992801chloroprocaine HCl 1 % Injectable SolutionPSNa844e68a-1462-40e4-be5e-f56214906eb96
1794184chloroprocaine HCl 2 % in 20 ML InjectionPSNa844e68a-1462-40e4-be5e-f56214906eb96
992805chloroprocaine HCl 2 % Injectable SolutionPSNa844e68a-1462-40e4-be5e-f56214906eb96
992809chloroprocaine HCl 3 % in 20 ML InjectionPSNa844e68a-1462-40e4-be5e-f56214906eb96
992803Nesacaine 1 % Injectable SolutionPSNa844e68a-1462-40e4-be5e-f56214906eb96
1794186Nesacaine 2 % in 20 ML InjectionPSNa844e68a-1462-40e4-be5e-f56214906eb96
992807Nesacaine 2 % Injectable SolutionPSNa844e68a-1462-40e4-be5e-f56214906eb96
992811Nesacaine 3 % in 20 ML InjectionPSNa844e68a-1462-40e4-be5e-f56214906eb96
179418620 ML chloroprocaine hydrochloride 20 MG/ML Injection [Nesacaine]SBDa844e68a-1462-40e4-be5e-f56214906eb96
99281120 ML chloroprocaine hydrochloride 30 MG/ML Injection [Nesacaine]SBDa844e68a-1462-40e4-be5e-f56214906eb96
992803chloroprocaine hydrochloride 10 MG/ML Injectable Solution [Nesacaine]SBDa844e68a-1462-40e4-be5e-f56214906eb96
992807chloroprocaine hydrochloride 20 MG/ML Injectable Solution [Nesacaine]SBDa844e68a-1462-40e4-be5e-f56214906eb96
179418420 ML chloroprocaine hydrochloride 20 MG/ML InjectionSCDa844e68a-1462-40e4-be5e-f56214906eb96
99280920 ML chloroprocaine hydrochloride 30 MG/ML InjectionSCDa844e68a-1462-40e4-be5e-f56214906eb96
992801chloroprocaine hydrochloride 10 MG/ML Injectable SolutionSCDa844e68a-1462-40e4-be5e-f56214906eb96
992805chloroprocaine hydrochloride 20 MG/ML Injectable SolutionSCDa844e68a-1462-40e4-be5e-f56214906eb96
179418620 ML Nesacaine 20 MG/ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
99281120 ML Nesacaine 30 MG/ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
992801chloroprocaine hydrochloride 1 % Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
992805chloroprocaine hydrochloride 2 % Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
1794184chloroprocaine hydrochloride 2 % per 20 ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
992809chloroprocaine hydrochloride 3 % per 20 ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
992803Nesacaine 1 % Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
992803Nesacaine 10 MG/ML Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
992807Nesacaine 2 % Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
1794186Nesacaine 2 % per 20 ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
992807Nesacaine 20 MG/ML Injectable SolutionSYa844e68a-1462-40e4-be5e-f56214906eb96
992811Nesacaine 3 % per 20 ML InjectionSYa844e68a-1462-40e4-be5e-f56214906eb96
1794184chloroprocaine HCl 2 % in 20 ML InjectionPSN9611d194-b6dd-93f4-e053-2a95a90a18165
179418420 ML chloroprocaine hydrochloride 20 MG/ML InjectionSCD9611d194-b6dd-93f4-e053-2a95a90a18165
1794184chloroprocaine hydrochloride 2 % per 20 ML InjectionSY9611d194-b6dd-93f4-e053-2a95a90a18165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-477-016332304770120 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-477-276332304772725 VIAL, SINGLE-DOSE in 1 TRAY (63323-477-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-477-01) 2010-10-140000-00-00NoNoCurrent