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Hydrochlorothiazide

Hydrochlorothiazide Tablets, USP

Approved
Approval ID

f20e4b9d-2f50-412f-9710-223af851078b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 24, 2012

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code42254-132
Application NumberANDA040807
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2011
FDA Product Classification

INGREDIENTS (6)

HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Hydrochlorothiazide - FDA Drug Approval Details