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Chlorthalidone

Approved
Approval ID

da829c8c-ae13-510b-e053-2995a90a70b8

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 1, 2023

Manufacturers
FDA

Northwind Pharmaceuticals

DUNS: 036986393

Products 1

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

Chlorthalidone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-790
Application NumberANDA207222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorthalidone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification

INGREDIENTS (9)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CHLORTHALIDONEActive
Quantity: 25 mg in 1 1
Code: Q0MQD1073Q
Classification: ACTIB

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Chlorthalidone - FDA Drug Approval Details