HYDROXYZINE PAMOATE (Page 2 of 2)

HOW SUPPLIED

Hydroxyzine Pamoate Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)are available as 25 mg capsules: two-tone green capsules, cap and body imprinted EP136 in black ink. They are supplied as follows:

30 CAPSULE in a BOTTLE (53217-256-30)
60 CAPSULE in a BOTTLE (53217-256-60)

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

Dispense in tight, light resistant containers (USP).

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Principal display panel-25mg label

Image Description
(click image for full-size original)

SPL Image

HYDROXYZINE PAMOATE hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-256(NDC:64980-169)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C RED NO. 40
FD&C BLUE NO. 1
Product Characteristics
Color GREEN (BLACK) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code EP136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-256-30 30 CAPSULE in 1 BOTTLE None
2 NDC:53217-256-60 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201507 11/17/2010
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2017 Aidarex Pharmaceuticals LLC

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