chloroprocaine Injectable Solution

Brand(s)
Nesacaine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
App Pharmaceuticals, Llc (2014-09-17)
Oldest Current Product
1982-04-16
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\CHLOROPROCAINE
FDAOB
INJECTION\INJECTION\CHLOROPROCAINE HYDROCHLORIDE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\CHLOROPROCAINE HYDROCHLORIDE
INFILTRATION\INJECTION, SOLUTION\CHLOROPROCAINE HYDROCHLORIDE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\CHLOROPROCAINE
INFILTRATION\INJECTION, SOLUTION\CHLOROPROCAINE

product(s) by strength(s)

chloroprocaine hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230475NesacaineNDAApp Pharmaceuticals, Llc2010-10-14CHLOROPROCAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTIONNDA009435a844e68a-1462-40e4-be5e-f56214906eb9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840475NesacaineNDAGeneral Injecatables & Vaccines, Inc2011-10-03CHLOROPROCAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTION633230475NDA009435baa6a68a-92c8-4a11-8fbf-fa5d91969035

chloroprocaine hydrochloride 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230476NesacaineNDAApp Pharmaceuticals, Llc2010-10-14CHLOROPROCAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTIONNDA009435a844e68a-1462-40e4-be5e-f56214906eb9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094169ANDAHospira, Inc.1982-04-16CHLOROPROCAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA087447ec4ab877-878f-4b0e-3eb6-106a606479ad

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840476NesacaineNDAGeneral Injecatables & Vaccines, Inc2013-01-30CHLOROPROCAINE HYDROCHLORIDEINFILTRATIONINJECTION, SOLUTION633230476NDA00943522cc5200-6998-4c70-a51a-49bf2ad8c52b

chloroprocaine hydrochloride 30 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230478NesacaineNDAApp Pharmaceuticals, Llc2010-10-14CHLOROPROCAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONNDA009435a844e68a-1462-40e4-be5e-f56214906eb9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004094170ANDAHospira, Inc.1982-04-16CHLOROPROCAINE HYDROCHLORIDEEPIDURALINJECTION, SOLUTIONANDA087446ec4ab877-878f-4b0e-3eb6-106a606479ad

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040273CHLOROPROCAINE HYDROCHLORIDEEUROHEALTH INTERNATIONAL SARL1998-09-09ANDA040273_001, ANDA040273_002
2ANDA087446CHLOROPROCAINE HYDROCHLORIDEHOSPIRA INC1982-04-16ANDA087446_001
3ANDA087447CHLOROPROCAINE HYDROCHLORIDEHOSPIRA INC1982-04-16ANDA087447_001
4NDA009435NESACAINEFRESENIUS KABI USA LLCNDA009435_001, NDA009435_002, NDA009435_003, NDA009435_004, NDA009435_006, NDA009435_007

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040273_001RXCHLOROPROCAINE HYDROCHLORIDE (2%)INJECTIONFalseAP1998-09-09CHLOROPROCAINE HYDROCHLORIDE
2ANDA040273_002RXCHLOROPROCAINE HYDROCHLORIDE (3%)INJECTIONFalseAP1998-09-09CHLOROPROCAINE HYDROCHLORIDE
3ANDA087446_001RXCHLOROPROCAINE HYDROCHLORIDE (3%)INJECTIONFalseAP1982-04-16CHLOROPROCAINE HYDROCHLORIDE
4ANDA087447_001RXCHLOROPROCAINE HYDROCHLORIDE (2%)INJECTIONFalseAP1982-04-16CHLOROPROCAINE HYDROCHLORIDE
5NDA009435_001RXCHLOROPROCAINE HYDROCHLORIDE (1%)INJECTIONTrueNESACAINE
6NDA009435_002RXCHLOROPROCAINE HYDROCHLORIDE (2%)INJECTIONFalseAPNESACAINE
7NDA009435_003discontinuedCHLOROPROCAINE HYDROCHLORIDE (2%)INJECTIONFalseNESACAINE
8NDA009435_004discontinuedCHLOROPROCAINE HYDROCHLORIDE (3%)INJECTIONFalseNESACAINE
9NDA009435_006RXCHLOROPROCAINE HYDROCHLORIDE (2%)INJECTIONTrueAP1996-05-02NESACAINE
10NDA009435_007RXCHLOROPROCAINE HYDROCHLORIDE (3%)INJECTIONTrueAP1996-05-02NESACAINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122cc5200-6998-4c70-a51a-49bf2ad8c52b (view SPL)Nesacaine 2% (Chloroprocaine HCL) 20 mg/mL 30 mLprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-01-241525840476
2a844e68a-1462-40e4-be5e-f56214906eb9 (view SPL)Nesacaine and Nesacaine MPFprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-173633230475, 633230476, 633230478, 633230477
3baa6a68a-92c8-4a11-8fbf-fa5d91969035 (view SPL)Nesacaine 1% 10mg/mL 30mL Multiple Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-10-031525840475
4ec4ab877-878f-4b0e-3eb6-106a606479ad (view SPL)ChloroprocaineHydrochlorideInjection, USPprescriptionHuman PrescriptionHospira, Inc.2014-07-035004094169, 004094170

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII