Hydrochlorothiazide: Package Insert and Label Information (Page 2 of 2)

DOSAGE AND ADMINISTRATION

For Control of Hypertension: The adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

HOW SUPPLIED

Hydrochlorothiazide capsules USP, 12.5 mg are supplied in Teal Blue opaque/ Teal Blue opaque size ‘4’ hard gelatin capsules radially imprinted ‘A129’ on cap and ‘12.5 mg’ on body in black ink, filled with white to off-white powder.

NDC 62332-070-30 bottle of 30 capsules

NDC 62332-070-31 bottle of 100 capsules

NDC 62332-070-71 bottle of 500 capsules

NDC 62332-070-91 bottle of 1000 capsules

NDC 62332-070-10 carton of 100 (10 x 10) unit-dose capsules
Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.

Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Panelav 389350, Gujarat, India

Manufactured for:

Alembic Pharmaceuticals, Inc.

750 Route 202, Bridgewater, NJ 08807

USA

Revised: 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62332-070-30
Hydrochlorothiazide
Capsules, USP
12.5 mg
Rx only
30 Capsules Alembic

HYDROCHLOROTHIAZIDE hydrochlorothiazide capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-070 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN LACTOSE MONOHYDRATE SILICON DIOXIDE MAGNESIUM STEARATE D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN, UNSPECIFIED TITANIUM DIOXIDE FERROSOFERRIC OXIDE

Product Characteristics Color BLUE (Teal Blue opaque) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code A129;12;5mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62332-070-30 30 CAPSULE in 1 BOTTLE None 2 NDC:62332-070-31 100 CAPSULE in 1 BOTTLE None 3 NDC:62332-070-71 500 CAPSULE in 1 BOTTLE None 4 NDC:62332-070-91 1000 CAPSULE in 1 BOTTLE None 5 NDC:62332-070-10 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (62332-070-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200645 03/02/2017

Labeler — Alembic Pharmaceuticals Inc. (079288842)

Registrant — Alembic Pharmaceuticals Limited (650574663)

Establishment
Name	Address	ID/FEI	Operations
Alembic Pharmaceuticals Limited		650574671	MANUFACTURE (62332-070)

Revised: 09/2020 Alembic Pharmaceuticals Inc.