Prescription Drug Information: Hydroxyzine Pamoate (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 100 Capsule Bottle Label (25mg)

NDC 59762-5410-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

25 mg*

Rx only

PRINCIPAL DISPLAY PANEL -- 100 Capsule Bottle Label (25mg)
(click image for full-size original)
HYDROXYZINE PAMOATE
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-5420
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
D&C RED NO. 33
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
SUCROSE
Product Characteristics
Color GREEN, WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Vistaril;Pfizer;542
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-5420-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA011459 07/15/2020
HYDROXYZINE PAMOATE
hydroxyzine pamoate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-5410
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROXYZINE PAMOATE (HYDROXYZINE) HYDROXYZINE DIHYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
D&C RED NO. 33
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
SUCROSE
Product Characteristics
Color GREEN (two-tone green) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Vistaril;Pfizer;541
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-5410-1 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA011459 07/15/2020 07/15/2020
Labeler — Greenstone LLC (825560733)
Registrant — Pfizer Inc (113480771)

Revised: 06/2023 Greenstone LLC

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