Hydroxyzine Injectable Solution

Brand(s)
Vistaril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
American Regent, Inc. (2015-09-24)
Oldest Current Product
1957-09-18
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\HYDROXYZINE
FDAOB
INJECTION\INJECTION\HYDROXYZINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROXYZINE HYDROCHLORIDE
INTRAMUSCULAR\SOLUTION\HYDROXYZINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROXYZINE
INTRAMUSCULAR\SOLUTION\HYDROXYZINE

product(s) by strength(s)

hydroxyzine hydrochloride 25 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005174201ANDAAmerican Regent, Inc.1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0874088af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840201ANDAGeneral Injecatables & Vaccines, Inc2010-03-01HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005174201ANDA0874087def1daa-c800-4263-9526-eac8d53e4636
2551545728ANDACardinal Health1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005174201ANDA0874085209ce5b-c14f-44d8-add5-e4de41dc6684

hydroxyzine hydrochloride 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005175601ANDAAmerican Regent, Inc.1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0874088af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a
2005175602ANDAAmerican Regent, Inc.1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0874088af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a
3005175610ANDAAmerican Regent, Inc.1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA0874088af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000495460VistarilNDARoerig1957-09-18HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARSOLUTIONNDA011111aed7d120-5f3d-4276-b341-737244d4f8a5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840007ANDAGeneral Injecatables & Vaccines, Inc2010-03-01HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005175602ANDA0874089c6ec419-5d3b-4053-9970-42a30458b92a
2525840601ANDAGeneral Injecatables & Vaccines, Inc2010-03-01HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005175601ANDA087408ba605c0d-7185-4195-965d-379990eb4b4e
3525840610ANDAGeneral Injecatables & Vaccines, Inc2010-03-01HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005175610ANDA087408d834dad1-aedc-48d8-941d-3de56ce04069
4551545725ANDACardinal Health1990-09-30HYDROXYZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005175601ANDA0874085209ce5b-c14f-44d8-add5-e4de41dc6684

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA085551HYDROXYZINETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CAREANDA085551_001, ANDA085551_002
2ANDA085778HYDROXYZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085778_001
3ANDA085779HYDROXYZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA085779_001
4ANDA086258HYDROXYZINE HYDROCHLORIDETrueWYETH AYERST LABORATORIESANDA086258_001, ANDA086258_002
5ANDA086821HYDROXYZINE HYDROCHLORIDETrueHOSPIRA INCANDA086821_001
6ANDA086822HYDROXYZINE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INCANDA086822_001
7ANDA087014ORGATRAXTrueORGANON USA INCANDA087014_001, ANDA087014_002
8ANDA087273HYDROXYZINE HYDROCHLORIDETrueALTANA INC1982-04-20ANDA087273_001, ANDA087273_002
9ANDA087274HYDROXYZINE HYDROCHLORIDETrueWATSON LABORATORIES INCANDA087274_001, ANDA087274_002
10ANDA087310HYDROXYZINE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INCANDA087310_001
11ANDA087329HYDROXYZINE HYDROCHLORIDEFRESENIUS KABI USA LLCANDA087329_001, ANDA087329_002
12ANDA087408HYDROXYZINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INCANDA087408_001, ANDA087408_002
13ANDA087416HYDROXYZINE HYDROCHLORIDETrueHOSPIRA INCANDA087416_001
14ANDA087546HYDROXYZINE HYDROCHLORIDETrueHOSPIRA INCANDA087546_001
15ANDA087591HYDROXYZINE HYDROCHLORIDETrueSOLOPAK LABORATORIES INCANDA087591_001
16ANDA087592HYDROXYZINE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEWANDA087592_001
17ANDA087593HYDROXYZINE HYDROCHLORIDETrueSOLOPAK LABORATORIES INCANDA087593_001
18ANDA087595HYDROXYZINE HYDROCHLORIDETrueSOLOPAK LABORATORIES INCANDA087595_001
19ANDA087596HYDROXYZINE HYDROCHLORIDETrueSOLOPAK MEDICAL PRODUCTS INCANDA087596_001
20ANDA088184HYDROXYZINE HYDROCHLORIDETrueFRESENIUS KABI USA LLC1983-03-31ANDA088184_001
21ANDA088185HYDROXYZINE HYDROCHLORIDETrueFRESENIUS KABI USA LLC1983-03-31ANDA088185_001
22ANDA088862HYDROXYZINE HYDROCHLORIDETruePHARMAFAIR INC1986-02-14ANDA088862_001
23ANDA088881HYDROXYZINE HYDROCHLORIDETruePHARMAFAIR INC1986-02-14ANDA088881_001
24ANDA089106HYDROXYZINE HYDROCHLORIDETruePHARMAFAIR INC1986-02-14ANDA089106_001
25ANDA089107HYDROXYZINE HYDROCHLORIDETruePHARMAFAIR INC1986-02-14ANDA089107_001
26NDA011111VISTARILTruePFIZER LABORATORIES DIV PFIZER INCNDA011111_001, NDA011111_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA085551_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE
2ANDA085551_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE
3ANDA085778_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
4ANDA085779_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
5ANDA086258_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
6ANDA086258_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
7ANDA086821_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
8ANDA086822_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
9ANDA087014_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseORGATRAX
10ANDA087014_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseORGATRAX
11ANDA087273_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1982-04-20HYDROXYZINE HYDROCHLORIDE
12ANDA087273_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1982-04-20HYDROXYZINE HYDROCHLORIDE
13ANDA087274_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
14ANDA087274_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
15ANDA087310_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
16ANDA087329_001RXHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONTrueAPHYDROXYZINE HYDROCHLORIDE
17ANDA087329_002RXHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONTrueAPHYDROXYZINE HYDROCHLORIDE
18ANDA087408_001RXHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseAPHYDROXYZINE HYDROCHLORIDE
19ANDA087408_002RXHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseAPHYDROXYZINE HYDROCHLORIDE
20ANDA087416_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
21ANDA087546_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
22ANDA087591_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
23ANDA087592_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
24ANDA087593_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
25ANDA087595_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
26ANDA087596_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseHYDROXYZINE HYDROCHLORIDE
27ANDA088184_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1983-03-31HYDROXYZINE HYDROCHLORIDE
28ANDA088185_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1983-03-31HYDROXYZINE HYDROCHLORIDE
29ANDA088862_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1986-02-14HYDROXYZINE HYDROCHLORIDE
30ANDA088881_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1986-02-14HYDROXYZINE HYDROCHLORIDE
31ANDA089106_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalse1986-02-14HYDROXYZINE HYDROCHLORIDE
32ANDA089107_001discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalse1986-02-14HYDROXYZINE HYDROCHLORIDE
33NDA011111_001discontinuedHYDROXYZINE HYDROCHLORIDE (25MG/ML)INJECTIONFalseVISTARIL
34NDA011111_002discontinuedHYDROXYZINE HYDROCHLORIDE (50MG/ML)INJECTIONFalseVISTARIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15209ce5b-c14f-44d8-add5-e4de41dc6684 (view SPL)Hydroxyzine Hydrochloride Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-192551545725, 551545728
27def1daa-c800-4263-9526-eac8d53e4636 (view SPL)Hydroxyzine HCL 25 mg/mL Injection, USP 1mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-01-233525840201
38af7e5ce-d9d9-44cc-9f2f-4ddbc89e758a (view SPL)Hydroxyzine Hydrochloride Injection, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2015-09-248005174201, 005175601, 005175602, 005175610
49c6ec419-5d3b-4053-9970-42a30458b92a (view SPL)Hydroxyzine HCL 50 mg/mL Injection, USP 2 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-01-232525840007
5aed7d120-5f3d-4276-b341-737244d4f8a5 (view SPL)VISTARIL hydroxyzine hydrochlorideINTRAMUSCULAR SOLUTIONFor Intramuscular Use OnlyprescriptionHuman PrescriptionRoerigMANUFACTURE2010-06-243000495460
6ba605c0d-7185-4195-965d-379990eb4b4e (view SPL)Hydroxyzine HCL 50 mg/mL Injection, USP 1mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-01-233525840601
7d834dad1-aedc-48d8-941d-3de56ce04069 (view SPL)Hydroxyzine HCL 50 mg/mL Injection USP 10 mL Multi Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-01-232525840610

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