MECLIZINE HYDROCHLORIDE

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

PSS World Medical Inc.

DUNS Number

101822682

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

STAT Rx USA LLC

Labeler

STAT Rx USA LLC

Registrant

PSS World Medical Inc.

DUNS Number

786036330

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

16590-301

Application Number

ANDA087127

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 20, 2012

Ingredients

MeclizineActive

Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT