Hydrochlorothiazide
HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg Rx only
Approved
Approval ID
27a7e751-8aca-440e-95e4-cfecae1a2465
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-747
Application NumberANDA202556
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (7)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT