NDC Code(s) : 70710-1161-3, 70710-1161-9, 70710-1161-1, 70710-1161-0, 70710-1161-2, 70710-1161-4, 70710-1162-3, 70710-1162-9, 70710-1162-1, 70710-1162-0, 70710-1162-2, 70710-1162-4
Packager : Zydus Pharmaceuticals (USA) Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Meclizine HydrochlorideMeclizine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE(UNII: HDP7W44CIO)
(MECLIZINE - UNII:3L5TQ84570) 		MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color BLUE (light blue to blue) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code 1161
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70710-1161-330 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
2NDC:70710-1161-990 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
3NDC:70710-1161-1100 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
4NDC:70710-1161-01000 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
5NDC:70710-1161-410 in 1 CARTON 29/10/2020
5NDC:70710-1161-210 in 1 BLISTER PACK Type 0: Not a Combination Product29/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213957 10/29/2020
Meclizine HydrochlorideMeclizine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE(UNII: HDP7W44CIO)
(MECLIZINE - UNII:3L5TQ84570) 		MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color YELLOW (light yellow to yellow) Score no score
Shape OVAL Size 13 mm
Flavor Imprint Code 1162
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70710-1162-330 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
2NDC:70710-1162-990 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
3NDC:70710-1162-1100 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
4NDC:70710-1162-01000 in 1 BOTTLE Type 0: Not a Combination Product29/10/2020
5NDC:70710-1162-410 in 1 CARTON 29/10/2020
5NDC:70710-1162-210 in 1 BLISTER PACK Type 0: Not a Combination Product29/10/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213957 10/29/2020

LABELER - Zydus Pharmaceuticals (USA) Inc.(156861945)

REGISTRANT - Zydus Worldwide DMCC(557951127)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(70710-1161, 70710-1162), MANUFACTURE(70710-1161, 70710-1162)

PRINCIPAL DISPLAY PANEL

NDC 70710-1161-1

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

Rx Only

Zydus

label

NDC 70710-1162-1

Meclizine Hydrochloride Tablets, USP

25 mg

100 Tablets

Rx Only

Zydus

label