FDA.reportPublic FDA data

Chloroprocaine Hydrochloride

Product NDC
0143-9210
11-digit product format
001439210
Labeler code
0143
Product ID
0143-9210_a652f290-f8c6-4483-9fe4-b1fd50dec37d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chloroprocaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040273
Marketing category
ANDA
Marketing start
1998-11-01
Substance
CHLOROPROCAINE HYDROCHLORIDE
Active strength
30 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
Chloroprocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOROPROCAINE HYDROCHLORIDE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLT7Z1YW11H
Rxcui992809, 1794184

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
0143-9210-01Chloroprocaine Hydrochloride20 mL in 1 VIALINJECTION, SOLUTION204
0143-9210-10Chloroprocaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9210-01ML - Milliliter0143-921008eb954a-ca0d-4ffc-9234-9d392a638a3c12017-10-13
0143-9210-10ML - Milliliter0143-921072d27c55-49f6-4ecb-9050-51081e0852a212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9210CHLOROPROCAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20220304_e21e24d5-0535-4962-b9ed-7957fe4ed3db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794184chloroprocaine HCl 2 % in 20 ML InjectionPSNe21e24d5-0535-4962-b9ed-7957fe4ed3db4
992809chloroprocaine HCl 3 % in 20 ML InjectionPSNe21e24d5-0535-4962-b9ed-7957fe4ed3db4
179418420 ML chloroprocaine hydrochloride 20 MG/ML InjectionSCDe21e24d5-0535-4962-b9ed-7957fe4ed3db4
99280920 ML chloroprocaine hydrochloride 30 MG/ML InjectionSCDe21e24d5-0535-4962-b9ed-7957fe4ed3db4
1794184chloroprocaine hydrochloride 2 % per 20 ML InjectionSYe21e24d5-0535-4962-b9ed-7957fe4ed3db4
992809chloroprocaine hydrochloride 3 % per 20 ML InjectionSYe21e24d5-0535-4962-b9ed-7957fe4ed3db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9210-010014392100120 mL in 1 VIAL20 mlHistorical
0143-9210-100014392101010 VIAL in 1 CARTON (0143-9210-10) / 20 mL in 1 VIAL (0143-9210-01) 10 vial1998-11-010000-00-00NoNoCurrent