Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Quality Care Products, LLC
Quality Care Products, LLC
831276758
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meclizine Hydrochloride
Product Details
NDC Product Code
55700-919Application Number
NDA010721Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
September 22, 2021STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MeclizineActive
Code: HDP7W44CIOClass: ACTIBQuantity: 12.5 mg in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT