Antivert
These highlights do not include all the information needed to use ANTIVERTsafely and effectively. See full prescribing information for ANTIVERT. ANTIVERT(meclizine HCl) tablets, for oral use ANTIVERT(meclizine HCl) chewable tablets, for oral use Initial U.S. Approval: 1957
Approved
Approval ID
4a5d81fc-ad25-4c3f-a91c-93fe334c02e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Casper Pharma LLC
DUNS: 080025838
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
meclizine hcl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70199-018
Application NumberNDA010721
Product Classification
M
Marketing Category
C73594
G
Generic Name
meclizine hcl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (9)
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
RASPBERRYInactive
Code: 4N14V5R27W
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
meclizine hcl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70199-004
Application NumberNDA010721
Product Classification
M
Marketing Category
C73594
G
Generic Name
meclizine hcl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
meclizine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70199-003
Application NumberNDA010721
Product Classification
M
Marketing Category
C73594
G
Generic Name
meclizine HCl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
meclizine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70199-002
Application NumberNDA010721
Product Classification
M
Marketing Category
C73594
G
Generic Name
meclizine HCl
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2022
FDA Product Classification
INGREDIENTS (9)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MECLIZINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 1 1
Code: HDP7W44CIO
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT