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Hydrochlorothiazide

Hydrochlorothiazide Tablets, USP

Approved
Approval ID

d7d0867a-748e-4960-851f-ad764e07f774

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 20, 2025

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71335-1976
Application NumberANDA040907
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 20, 2025
FDA Product Classification

INGREDIENTS (7)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/30/2011

Hydrochlorothiazide 50mg Tablet

Label

DESCRIPTION SECTION

LOINC: 34089-3Updated: 10/13/2020

DESCRIPTION

Hydrochlorothiazide, USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula:

Hydrochlorothiazide

Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide, USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 8/20/2025

HOW SUPPLIED

Hydrochlorothiazide Tablets, USP are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "U" and "129" debossed across the score line on one side and plain on other side containing 50 mg of hydrochlorothiazide, USP.

NDC: 71335-1976-1: 30 Tablets in a BOTTLE

NDC: 71335-1976-2: 60 Tablets in a BOTTLE

NDC: 71335-1976-3: 90 Tablets in a BOTTLE

NDC: 71335-1976-4: 28 Tablets in a BOTTLE

NDC: 71335-1976-5: 56 Tablets in a BOTTLE

NDC: 71335-1976-6: 100 Tablets in a BOTTLE

NDC: 71335-1976-7: 7 Tablets in a BOTTLE

NDC: 71335-1976-8: 14 Tablets in a BOTTLE

NDC: 71335-1976-9: 120 Tablets in a BOTTLE

NDC: 71335-1976-0: 45 Tablets in a BOTTLE

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required)

Store at 20° to 25° C (68° to 77° F)

[see USP Controlled Room Temperature].

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

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Hydrochlorothiazide - FDA Drug Approval Details