Hydroxyzine Hydrochloride (Page 2 of 2)

HOW SUPPLIED

HydrOXYzine Hydrochloride Tablets, USP 10 mg, 25 mg and 50 mg are supplied as follows:

10 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘275 ’ on other.

Bottles of 100 NDC # 68462-352-01
Bottles of 500 NDC # 68462-352-05

25 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘276 ’ on other.

Bottles of 100 NDC # 68462-353-01
Bottles of 500 NDC # 68462-353-05

50 mg Tablets: Beige, film coated, round, biconvex tablets debossed with ‘IG ’ on one side and ‘277 ’ on other.

Bottles of 100 NDC # 68462-354-01
Bottles of 500 NDC # 68462-354-05

Dispense in a tight container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured by:

InvaGen Pharmaceuticals, Inc.
Hauppauge, NY 11788

Manufactured for:

logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkgenerics.com

Rev: 12/14

Package/Label Display Panel

NDC 68462-352-01

HydrOXYzine HCl Tablets, USP 10 mg

10mg-label
(click image for full-size original)

Package/Label Display Panel

NDC 68462-353-01

HydrOXYzine HCl Tablets, USP 25 mg

25mg-label
(click image for full-size original)

Package/Label Display Panel

NDC 68462-354-01

HydrOXYzine HCl Tablets, USP 50 mg

50mg-label
(click image for full-size original)
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-352
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code IG;275
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-352-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-352-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040812 02/01/2015
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-353
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code IG;276
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-353-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-353-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040812 02/01/2015
HYDROXYZINE HYDROCHLORIDE
hydroxyzine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-354
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE) HYDROXYZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
Product Characteristics
Color BROWN (beige) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IG;277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-354-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-354-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040812 02/01/2015
Labeler — Glenmark Generics Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Invagen Pharmaceuticals Inc 165104469 ANALYSIS (68462-352), ANALYSIS (68462-353), ANALYSIS (68462-354), MANUFACTURE (68462-352), MANUFACTURE (68462-353), MANUFACTURE (68462-354)

Revised: 01/2015 Glenmark Generics Inc., USA

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