MECLIZINE HYDROCHLORIDE
Meclizine Hydrochloride
Approved
Approval ID
c65aee98-bddf-4cf7-8d78-17253704b1ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Meclizine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0089
Application NumberANDA087127
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2011
FDA Product Classification
INGREDIENTS (9)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Meclizine HydrochlorideActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Meclizine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0077
Application NumberANDA087128
Product Classification
M
Marketing Category
C73584
G
Generic Name
Meclizine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2011
FDA Product Classification
INGREDIENTS (10)
Meclizine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT