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Drug Product Composition: Hydroxyzine Pamoate

Hydroxyzine Pamoate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 7 USDMF, 1 JDMF, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 41 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE, CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

RELATED EXCIPIENT COMPANIES

6 DKSH, 4 ACG Worldwide, 1 Gangwal Chemicals, 3 Lonza Capsugel, 1 Qualicaps, 2 Roquette

EXCIPIENTS BY APPLICATIONS

8 Empty Capsules, 5 Coating Systems & Additives, 4 Thickeners and Stabilizers, 4 Fillers, Diluents & Binders, 2 Film Formers & Plasticizers, 2 Coloring Agents, 1 Taste Masking

DIGITAL CONTENT

1 NEWS #PharmaBuzz

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

2 US Medicaid Prescriptions

MARKET PLACE

3 FDF Dossiers

3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

$ Xls

Filters

USFDA APPLICATION NUMBER - 11459 / DOSAGE - CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROXYZINE PAMOATE(UNII: M20215MUFR) (HYDROXYZINE - UNII:30S50YM8OG)	HYDROXYZINE	50mg

Inactive Ingredients

Ingredient Name	Cardinal Health	Lake Erie Medical DBA Quality Care Products LLC	Preferred Pharmaceuticals, Inc.	Mylan Institutional Inc.	REMEDYREPACK INC.	Heritage Pharmaceuticals Inc.	NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals,Inc.	St. Mary's Medical Park Pharmacy	REMEDYREPACK INC.	A-S Medication Solutions	A-S Medication Solutions LLC	Actavis Pharma, Inc.	American Health Packaging	AvKARE, Inc.	Bryant Ranch Prepack	Golden State Medical Supply, Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	NCS HealthCare of KY, LLC dba Vangard Labs	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	Proficient Rx LP
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C GREEN NO. 3(3P3ONR6O1S)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
INDIGOTINDISULFONATE SODIUM(D3741U8K7L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)